2018 NCOA ANNUAL MEETING SATURDAY HANDOUTS General Scientific Session

Home , Latarjet procedure

October 12-14, 2018 Kiawah Island Golf Resort, Kiawah Island, SC AAOS Update

Joseph A Bosco III, MD Second VP AAOS Professor and Vice Chair NYU Langone Department of Orthopedic Surgery

2018 NCOA Annual Meeting Kiawah Island, SC October 13, 2018

UNC Resident 1986-1991

2018 Key Strategic Initiatives

Governance & Strategy: Building new, more effective models for governance and strategy

Member Value: Enhancing the value of your Academy relationship

Digital Education: Include more education as part of membership and improve online product offerings, engagement, & user experience

Registries: Expand registry products and influence to fully realize systems approach to continuous quality improvement

Partnership: Managing orthopaedic tribalism through partnerships

1 Strategic Plan Shaping the Future Given the pace of change and new Academy leadership, the Board of Directors approved a new Project Team to shape the next Strategic Plan.

1. Understand our members needs 2. Focus on our core competencies 3. Strategic Partnerships to create new member value and loyalty

Project Team Chair: Kristy L. Weber, MD

Governance Task Force

Objective: Review the existing governance structure of the Board to ensure that it can effectively Governance execute against an organizational strategy.

Goals: . Comprehensive assessment of AAOS How the Board sets governance structures direction and . Formulate a set of principles, tailored to develops strategy the AAOS, that specifies how AAOS Board will be structured and governed

. Identify and recommend changes to current AAOS governance

Task Force Chair: David A. Halsey, MD Target: December 2018

Membership

. Added new membership category for Physician Assistants

. Evaluating membership categories and offerings for other key allied health providers in musculoskeletal care

. Reviewing pathway for DO members to become full Fellows of the AAOS

2 Value of Membership ‐ Quantified

Benefits Non-Member Member Member Dues and AM Fee AAOS Annual Meeting $1,200 $100 Journal of the AAOS $466 $0 $1,095 Clinical Orthopaedics & Related Research $651 $0 AAOS Now $86 $0 Non-Member Costs (2.5x Member Cost) Headline News N/A $0 Online Learning $2,842 100+ modules available : estimated7 $10 per module N/A $0 Webinars (12 of 40 webinars are fee based) Total Value: $420 | Average Member Utilization: 4x per year $140 $0 Member Value Orthopaedic Video Theater $299 $0

Member Dues +$995 =$1,747 Total Cost $2,842 $1,095

References / Notes: 1. Registry Participation: $439 per physician anticipated participation costs for future out‐patient registries

Value of Membership ‐ Priceless

Benefit Strongest evidence of achievement for professional competence and commitment to ”Fellow” Designation – FAAOS excellence

Advocacy Supporting and protecting members on legislative and regulatory issues

CME Tracking / Transcript Service Track your CME in one place and have information automatically transferred to ABOS

Professional Compliance Program A means to address the issue of inappropriate or fraudulent expert witness testimony Orthoinfo.org 8 Supporting physicians to better educate and support their patients Career Center Explore and identify orthopaedic career opportunities

Leadership opportunities Impact the profession by volunteering on committees and education programs

CME for MOC Providing CME learning opportunities that count towards MOC

CPGs, AUCs, performance measures, and patient safety resources that set the standard Quality tools of care and define quality for our profession

Education Strategy

Mission To be the premier resource of orthopaedic learning.

Vision The Academy is the trusted, preferred resource for every orthopaedist throughout their career and is the partner of choice for subspecialty societies to develop and deliver orthopaedic education.

Priorities Customer Learning Strategic Experience & Expertise Partnerships Engagement

3 The Education Hub Strategy . Members are our priority – without them we are irrelevant. Why the . Education is a key member benefit, but with so many options, why choose us? “Hub” . The Hub Strategy enables us to deliver the best offerings so that members are Strategy? satisfied and renew, and it provides a sustainable revenue stream to fund the ecosystem.

Our Education MUST Provide Doing This Gives Us… Information in a Way That… The Education Hub: 10 What it IS and What it is NOT A business strategy to  Enhances what we are good at deliver valuable info to enhance our core asset . Engagement which increases ability  Is financially sustainable (members) and to connect to commercialize and enhance perceived member value  Is accessible them to what they need, when they need it  Connects us to partners (when . More, valuable content which leads needed) We are NOT everything to to higher renewal rates and  Prioritizes offerings everyone, we do NOT need expansion opportunities to own all of the content, and it is NOT a hosting strategy

Orthopaedic Video Theater

. New dynamic interface makes it easier to search, download, bookmark, and rate videos

. 700+videos from top experts worldwide

. 200+ videos now offering CME

. COMING SOON! Expanding to include user‐ submitted videos, specialty society channels, and industry channels

New Portal ⚬ More Content ⚬ Enhanced User Experience Member Benefit

New Interactive Online Learning Experiences at learn.aaos.org

. Self-assessment examinations

. Free content, including 100+ surgical techniques microlearning modules

. AAOS Practice Prep Plans

. Orthopaedic Video Theater surgical videos

. Resident education resources

4 Resident Education

Orthopaedic Video Theater: FREE to AAOS resident members

NEW Oncology Review Course: Interactive resource with 38 lessons, 5 modules developed by oncology luminaries

Improved ResStudy Platform

. Features a build-a-quiz tool and 3,000+ self-assessment questions

. Only resource for residents to review all the current AAOS exams and practice with real OITE questions

Supporting Your MOC Process and Achievements . Check on your CME credits and add new CME activity to your member transcript at aaos.org/transcript

. AAOS automatically sends your CME credits directly to ABOS to make MOC reporting easier

. SAE and Practice Prep Plans developed to help you meet your MOC requirements

. Supports the rollout of the ABOS Web-Based Longitudinal Assessment (ABOS WLA) to replace the high-stakes exam: Ongoing process of reviewing material and answering questions over time

Supporting Your MOC Process and Achievements What’s new in MOC?

. Web-based Longitudinal Assessment Program

. Practice-profiled recertification examinations eliminated all general orthopaedic questions

. Recertification exam options now available in General, Spine, Adult Recon, Pediatrics, Trauma, Foot & Ankle, Shoulder & Elbow, Surgery of the Hand, Sports Medicine, Oral (entirely practice-based)

. New Practice-profiled examinations in 2018: Pediatrics, Trauma, Foot & Ankle

5 Quality Resources

CLINICAL PRACTICE GUIDELINES AND AUCS OrthoGuidelines app developed for timely access . 18 clinical practice guidelines . 14 appropriate use criteria

NEW: . Management of Osteoarthritis of the Hip Guideline and AUC . Dysplasia of the Hip AUC

Awarded $1.5 million by the Department of Defense to develop six new guidelines and six new AUCs

Focus on bridging gap between science and clinical practice to define and improve quality Academy Board 17 End to end systems approach to continuous quality improvement that translates science into practice Approves significant, multi‐year investment in registries Leverage registries to collect data, report, and benchmark to define quality MSK care that is patient center, evidence based and cost effective June 2017 Invest in becoming a leader and partner to ensure quality in the delivery of MSK care

Relevance to the future of the profession and patients

Registries

. Component of a larger quality vision

. Provide data to inform AAOS guidelines and test performance measures

. Provide feedback to providers to continuously improve their practice and healthcare outcomes

18 . Allow AAOS to define what quality means in a value-based system

. Reduce the reporting burdens on physicians

. Help inform gaps in knowledge or areas for further education

“If you can’t measure it, you can’t improve it” ~ Drucker

6 Registries as a Strategic Priority to Provide Value to Members and Patients . Value of improved data collection and reporting

. National benchmarking through RegistryInsights™ allows providers to administer and analyze patient‐ reported outcomes . Reduce complications and revision rates . Increased transparency . Alerts for poorly performing implants . Support of quality initiatives . Monitor actions that improve patient care “Level II data introduces many variables . Allow for re-use of data towards programs like that health care providers may consider MIPS, MOC, CME when planning for surgery. Surgeons will be able to utilize this new data to better inform their decisions, and our ability to . In 2018, collection of Level II comorbidity and risk adjust will allow for their findings to complications clinical reporting translates into not be misconstrued.” risk-adjusted data reporting —Daniel J. Berry, MD

Registry Program Progress

. The American Joint Replacement Registry (AJRR) was re-integrated into AAOS . The Registry Oversight Committee (ROC) was created . Additional staff hired and physician leadership groups created . Shoulder & Elbow Registry identified as next priority. (Target: EOY 2018) . Strategy for building a scalable and sustainable Registry Program developed . Revamp of data specifications and problem-solving for improved data capture

Since October 2017

Advocating and Advancing Our Profession – 2018 Priorities Driven by the AAOS Advocacy Agenda . Ensuring orthopaedic priorities in the implementation of MACRA’s Quality Payment Program

. Supporting medical liability and antitrust reform

. Preserving in‐office ancillary services, physician owned hospitals, and other ownership issues

. Securing appropriations for orthopaedic research

. Championing orthopaedic concerns related to payment reform

7 Advocacy Wins on the National Stage . Passed IPAB repeal legislation through the U.S. House of Representatives . Attained increased protection for small, solo, . Passed medical liability reforms through the and rural practices under the Quality Payment U.S. House of Representatives Program

. Passed legislation to protect sports medicine . Submitted comments that resulted in the professionals through the U.S. House of Reps withdrawal of a harmful proposed rule on orthotics/prosthetics . Passed legislation to reform unfair antitrust laws and ensure insurance competition . Received unprecedented access/representation at over 600 political events via Orthopaedic PAC . Accomplished significant downsizing of mandatory CJR areas and cancellation of . Obtained CMS code change for total ankle SHFFT bundled payment model

Advocacy Wins at the State Level . South Carolina Supreme Court agreed with two orthopaedic surgeons in their long fight protecting the integration of physical therapy and physician services.

. Maryland Orthopaedic Association • Pennsylvania Orthopaedic Society successfully successfully advocated for a House advocated for a state bill that ends harmful measure to exempt a health care healthcare insurer practice of clawing back paid practitioner who has a specified claims. compensation arrangement with a healthcare entity from prohibition against • Puerto Rico’s Orthopaedic society (SPOT) self-referral as long as that challenged Medicare Advantage health insurers in compensation was from an advanced court over payment for disposables supplied by payment model. orthopaedic device companies for the use of implantation of a device during an orthopaedic . In Nevada, Georgia, Tennessee, and procedure. The court ruled in favor of SPOT. Maine, governors signed laws allowing visiting sports team physicians to practice in a state where they are not

North Carolina Advocacy Issues

. Certificate of Necessity: AAOS’s State Legislative and Regulatory Issues committee working to lift ban. Azar, FTC and DOJ are in favor. . Scope of Practice: Constant battle. AAOS OGR is a member of Scope of Practice Partnership

. Out of Network Billing: OGR working with NCOA opposing bill to tie payments to a percentage of Medicare

8 Project Goals Identify Best Practices Recognizing that specialty society partnership was critical, a project was kicked-off to: Synthesize & Present Insights 1. Identify what is going well Identify Partnership Frameworks 2. Biggest improvement opportunities 3. Best practices for maintain partnerships Develop Recommendations 4. Identify frameworks and best practices 5. Define processes and roles to support partnerships

What You Can Do to Stay Engaged and Active in Your Academy. Tell us what is on your mind. Participate in surveys and reach out to leadership with your ideas for how we can enhance the value of your Academy relationship.

. Ask questions, reach out, volunteer.

. Explore our growing offering of educational content at learn.aaos.org.

. Share your expertise ‐ submit an abstract for our Annual Meeting, a clinical research article for JAAOS, or story idea for AAOS Now.

. Foster the next generation –mentor a medical student, resident, or a Candidate Member. www.aaos.org/feedback

See you in Vegas!

2019 AAOS Annual Meeting March 12-16, 2019 Las Vegas, Nevada

aaos.org/annual

9 NCOS Meeting Kiawah Island October 13, 2018 9:45-10:05am

Conflicts of Interest in Orthopaedic and Spine Surgery: Where is the Fine Line?

James D. Kang MD

Thornhill Family Professor of Orthopaedic Surgery Harvard Medical School Chief of Orthopaedic Surgery Brigham and Women’s Hospital

Disclosures

• No Consulting • No Royalties or Stock Options in Orthopaedic Companies • Research Grants (in Ferguson Lab through Pitt) – NIH, OREF, AO Spine, CRSR, NASS – Stryker (basic science grant) In years Past – J & J (basic science grant) In years Past 2

This image cannot currently be displayed. Highest-Paid U.S. Doctors Get Rich With Fusion Surgery Debunked by Studies Q By Peter Waldman and David Armstrong - Dec 30, 2010 12:01 AM ET

Twin Cities Spine Center Patient testimonial of a bad outcome after fusion surgery

“Medtronics paid six of the 10 Twin Cities Spine surgeons….$1.75 Million in royalties and consulting fees in the first 9 months of this 3 year……” Bloomberg News

1 Legal Definition: Conflict of Interest

• A conflict of interest (COI) occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.

Levels of Conflicts in Medicine

• Consultants • Stock Options • Venture Capital Investments • Intellectual Property – Royalties from implants • Direct Payments (illegal) • Research Grants • Golf outing, Dinners, Gifts, Pens, etc…

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Ways to Mitigate COIs

• Removal • Disclosure • Recusal • Third Party Evaluations • Code of Ethics

2 Why Orthopaedic Surgery At Risk for Conflicts

• Large growth in implant use in past 20 years – Estimated $18 Billion for THR, TKR 2012 – Spine Implant costs not far behind • Large profits by industry • Decrease in Surgeon reimbursements over past 10-20 years

Surgeon Industry Collaboration: Definite Positives • Absolutely needed for technological advancements • Surgeon’s ideas and inventions need corporate support • Industry needs surgeons input into new developments for technical advancements

Great Examples

• Total Joints – Dr. Charnly – Dr. William Harris and Jorge Galante – Dr. Charles Eng – Dr. Harrington (spinal rods) – Dr. Sig Hansen (IM Nails) • Pioneers in Orthopaedics who also profited from ingenuity and great ideas that advanced orthoapedics 9

3 Why are Conflicts Potentially Dangerous?

• Not a problem if fully disclosed and ethical behavior rules • Relies on Physician to be unbiased and can make the right choice for treament • Large financial conflicts can make even the best physicians “go blind” • The patient becomes the innocent bystander who can get harmed

Full Disclosure of Conflicts: Transparency is a must but…..

Accuracy of conflict-of-interest disclosures reported by physicians. Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M.

• analyzed the reports of payments made to physicians by five manufacturers of total hip and knee prostheses in 2007 • disclosure statement was reviewed to determine whether the payment had been disclosed • rate of disclosure was 79.3% for directly related payments and 50.0% for indirectly related payments.

11 N Engl J Med. 2009 Oct 8;361(15):1466-74.

Conflict of interest in orthopaedic research. An association between findings and funding in scientific presentations. Okike K, Kocher MS, Mehlman CT, Bhandari M. Department of Orthopaedic Surgery, Children's Hospital, Harvard Medical School

• all podium presentations given at the 2001 and 2002 Annual Meetings of the American Academy of Orthopaedic Surgeons • Conflicts of interest were reported in 40.8% (212) of 519 abstracts. • factors that remained significant predictors of positive outcomes were royalties (p = 0.002) and consultant or employee status (p = 0.038).

12 J Bone Joint Surg Am. 2007 Mar;89(3):608-13.

4 Examples of Conflicts Gone Bad

Gives Medicine a Black Eye Makes us all look like idiots 13

Total Joint World

• Many Companies investigated by DOJ • Direct Payments to Surgeons for use of implants – Zimmer, Biomet, Stryker, DePuy, etc…..

New Focus of Inquiry Into Bribes: Doctors New York Times March 22, 2008

• Major Joint Implant companies settled to pay 300 Million in fines • DOJ set up Monitors at the company headquarters to oversee complicance • New focus by DOJ on the Surgeons (who solicited payments).. Ongoing…

5 Metal on Metal Arthroplasty Rationale

16 All theoretical advantages, no real preclinical studies were done Tom Fehring 2011

Metal on Metal Debacle

2008

https://www.youtube.com/watch?v=1z7mrFALro0&feature=youtu.be

Number of Complaints The Company’s internal documents And strategy ……..

2010 ASR hips (>93,000) recalled 2013 Pinnacle hip pulled from shelves 18 >10,000 pending lawsuits

6 Sports World

• PRP in sports medicine • Controversial – Consultants pushing treatment for every ailment in sports – No Good data to support efficacy – May not raise concerns by patients “if there is no harm in trying it.” – Efficacy in question but ?? Is it truly harmless??

“The Athlete's Pain As Sports Medicine Surges, Hope and Hype Outpace Proven Treatments”

20 New York Times Sept 4,2011

• Dr. Allan Mishra • Strong advocate for RPR use • Websites, YouTube, etc…. • Royalties from Biomet (RPR equipment) • Board of Director and Stock in BioParadox (cardiovascular applications) • Huge costs to patients, payors, but no real data. • Brings in patients and business…… 21

7 Trauma World

• BMP-2 use in Open Fxs • Kuklo – Bad fabricated data – ?Unethical behavior? – Did not disclose Medtronics Conflicts to Walter Reed when study was done

Former Army Doctor Accused of Research Fraud Takes Leave From University New York Times May 22, 2009

• Tim Kuklo (Walter Reed) published a prospective randomized study with very favorable results in healing of open tibia fractures in soldiers (JBJS British….) • His co-authors allege Dr. Kuklo forged signatures, and falsified data. • Dr. Kuklo was consultant to Medtronics (not disclosed to Walter Reed) • Entire study was retracted by JBJS-B

Basic Science Research

• Gene Therapy Trial • Jesse Gelsinger – Died of Adenovirus overload – PI (at Univ of Penn) President of Gene Therapy Society • Had huge conflicts in stock options in verture startup company

8 Teenager's Death Is Shaking Up Field of Human Gene-Therapy Experiments New York Times: January 27, 2000

• Dr. James Wilson (Professor at Penn) • President of Gene Therapy Society • Jesse“Targeted Gelsinger Genetics, (Liver bought enzyme Dr. Wilson’s deficiency..OTC) • Treatedcompany with five Adenovirus-OTC months later. He received construct $13.5 million in stock for his 30% share in the biotech • Diedcompany... or Anaphylaxis so much for to beingvirus an unpaid • Investigation:consultant.” Monkey data Father to of suggest patient this would happen • Dr. Wilson founded Genovo (startup company) major stock holder

Big Pharma…New York Times 9/8/18

Dr. Jose Baselga CMO Sloan Kettering Memorial Reported positive spin on a Roche sponsored study…

He received $3M in 2014… Never disclosed conflicts…26

Spine World

• BMP-2 Controversy • TDR Controversy

• Potentially Big waste of money and resources for no real clinical gains?

• Put patients at risk of adverse events 27

9 Physician Payments now fully disclosed by Orthopaedic Companies ON LINE…..

BMP-2 (InFuse) Debate

• Was nearing 1 Billion in sales/year • The most successful orthopaedic device in history • Originally FDA approved only for Anterior Lumbar Interbody Fusions in Titanium Cage device (LT Cage) • Majority of use now “off –label” use – Posterolateral fusions – Other Orthopaedic applications

Controversial Issues

• Original FDA trial done by consulting surgeons • All of the studies done later for off label use done by consulting surgeons • Every report seem to favor BMP- 2 over autograft and repeatedly stated the “safety” of BMP-2.

10 A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Carragee EJ, Hurwitz EL, Weiner BK. • Original studies found to have serious bias against ICBG control group • FDA documents and subsequent publications found to have serious inconsistencies • 40% increased risk of adverse events in Cervical spine • Higher rates of implant subsidence, urogenital events, retrograde ejaculation, and infection at higher rates compared to controls • In posterior fusions, higher risk of back pain, radiculitis, ectopic bone formation • Higher doses of BMP: association with apparent risk for malignancy

31 Spine J. 2011 Jun;11(6):471-91.

Pointed out that ICBG harvest is not as bad as made out to be by BMP advocates (mostly consultants)

Surgeons now have to carefully scrutinize the data to determine whether conflicts exist and whether to believe the conclusions.

Cancer Rates

Industry Location of Adverse Authors Industry Location of rhBMP Adverse Events Support rhBMP Events Support

Baskin et al (11) Yes Anterior Cervical None Carragee et al None Anterior Lumbar 7.2% incidence of retrograde (30) ejaculation Boakye et al (12) Yes Anterior Cervical None Pradhan et al (31) None Anterior Lumbar nonunion in rhBMP‐2 (56%) vs autograft (36%)

Boden et al (13) Yes Posterolateral None Shields et al (32) None Anterior Cervical soft tissue swelling 23%; Lumbar hematomas 9.9%

Boden et al (14) Yes Anterior Lumbar None Smucker et al (33) None Anterior Cervical soft tissue swelling 27.5%

Burkus et al (15) Yes Anterior Lumbar None Buttermann et al None Anterior Cervical soft tissue swelling 50‐62% (34) Burkus et al (16) Yes Anterior Lumbar None Anderson et al None Posterior Cervical 2 large seromas requiring (35) surgical debridement Burkus et al (17) Yes Anterior Lumbar None Robin et al (36) None Posterior Cervical large seroma with recurrance after two surgical wash outs

Burkus et al (5) Yes Anterior Lumbar None McClellan et al None Posterior Lumbar 69% osteolysis, 31% graft (37) Interbody subsidence Dawson et al (18) Yes Posterolateral None Helgeson et al None Posterior Lumbar Osteolysis 54% Lumbar (38) Interbody Dimar et al (19) Yes Posterolateral None Vaidya et al (39) None Posterior Lumbar Case report of seroma with Lumbar Interbody TLIF

Dimar et al (20) Yes Posterolateal None Haid et al (22) Yes Posterior Lumbar 75% heterotopic bone Lumbar Interbody formation Glassman et al Yes Posterolateral None Rhin et al (40) None Posterior Lumbar increased incidence of (21) Lumbar Interbody radiculitis Haid et al (22) Yes Posterior Lumbar None Sanfilippo et al None Posterior Lumbar 23% incidence of radiculitis Interbody Cage (41) Interbody at 6 months “Current and future uses of BMP Mindea et al (42) None Posterior Lumbar 11% incidence of radiculitis Interbody Latzman et al (43) None Anterior/Posterior 12.5% incidence of elevation in spine surgery” Lumbar in BUN/Cr FDA AMPLIFY Yes Lumbar 5% incidence of malignancy Eskander, Evan, Kang33 DATA (9) at 5 yrs compared to 1.8% in control JAAOS 2012

11 BMP and Cancer Risk

• “The documents obtained by the Senate committee show that Medtronic paid four of the article authors—Scott D. Boden, Regis W. Haid, Volker Sonntag and Thomas A. Zdeblick—between $22 million and $34 million each from 1996 to 2010.” • “In the 2007 (JBJS) Amplify article, which was co- authored by Drs. Boden, Glassman and Dimar, the disclosure read in part: "No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript."

Wall Street Journal/ CNN Oct 2012 34

TDR

• Wave of early enthusiasm • Strongly encouraged by original investigators doing the IDE studies • Early clinical results noted to be equal to fusion. • Potentially avoid adjacent level degeneration

TDR for LBP: IDE Study Critique

• FDA investigational device exemption study: • Non-inferiority study • 6/14 initial study sites declined to participate in 5yr FU • ↓ eligible patients 60% • Several exclusion criteria (osteoporosis, obesity, prior abdominal surgery, scoliosis) – 5% of patients indicated for lumbar surgery have no contraindications to TDR (Huang, Spine, 2004) – Of 100 patients who received surgery for LBP, all had contraindications for TDR (av 3.69, range 1-7) (Wang, Spine J, 2007) • Questionable long term outcomes • Extensive conflicts of interest initially not fully disclosed for Both Charite and ProDisc

Charite

Taken off market 4/10 36

12 New Reports of Complications by Non Conflicted Surgeons: Fracture and Dislocation

Charite ProDisc

TDR Wear Debris Osteolysis

(Devin, JBJS, 2008)38

Scott’s Parabola

Multiple center surgeries Strong media and peer High pressure complication rate Promising Idea Consultants’ COIs History

Encouraging Medicolegal reports Problem

13 NEJM 2013

Conclusions?

• In some instances, conflicts are hard to avoid, but doctors have a responsibility to manage them ethically with full disclosure • Physicians should not allow a conflict of interest to influence medical judgment. • Temptation leads to bad behavior • Bad behavior tarnishes the lofty goals of medicine

My Personal Opinions

• Unless you have a great invention, try to stay away from cozy agreements with industry • Consulting with companies are not a problem, but do it ethically – I prefer not to do it at all • My 2 mentors were role models – Henry Bohlman – Ed Hanley

14 Thank You

15 2018 NCOA ANNUAL MEETING SATURDAY HANDOUTS Biologics Breakout

October 12-14, 2018 Kiawah Island Golf Resort, Kiawah Island, SC A Novel Peripheral Nerve Allograft Bioscaffold

Daniel Lara II, MD, Xue Ma, MD, PhD, Zhongyu Li, MD, PhD, Thomas Smith PhD 10/13/2018 North Carolina Orthopaedic Society

Purpose

• To improve Acellular Nerve Allografts (ANA) • Optimizing decellularization and oxidation protocol • Seeding with supportive cells • Improve nerve regeneration following nerve repair

Hypothesis: Our novel acellular nerve allograft (ANA) can be seeded with supportive cells, promoting nerve regeneration.

Wake Forest Baptist Medical Center 2

Materials and Methods

• Decellularization with water and detergents removes cellular material without disrupting extracellular matrix (ECM) architecture. • Ingrowth of new cells is impeded due to tissue compartmentalization. • Oxidation increases the porosity of allografts • Decellularization and oxidation protocol

Wake Forest Baptist Medical Center 3

1 DNA Analysis

DNA Concentration: Decellularization and Oxidation: 32.49 ng/mL Commercial graft: 49.33 ng/mL

Wake Forest Baptist Medical Center 4

DAPI

Unseeded Seeded

Wake Forest Baptist Medical Center 5

SEM

Exterior of ANA that did not Interior of ANA that did not undergo oxidation. undergo oxidation.

Wake Forest Baptist Medical Center 6

2 SEM

Exterior oxidation 1.5% Interior oxidation 1.5% peracetic acid for 3 hrs peracetic acid for 3 hrs

Wake Forest Baptist Medical Center 7

SEM

Interior of oxidized ANA with seeded cells. 1.5% peracetic acid for 3 hrs

Wake Forest Baptist Medical Center 8

Conclusions

• Protocols used for the decellularization and oxidation of nerve allografts were successful. • Lower residual DNA concentration than commercially available grafts. • Allografts that underwent oxidation had increased porosity and were seedable with schwannoma cells. • The increased porosity will improve the ingrowth of new cells • Future in vivo studies will examine the use of these allografts in repairing nerve defects.

Wake Forest Baptist Medical Center 9

3 Osteoarthritis Biomarkers in Human Synovial Fluid of the Hip Joint

Andrew D. Francis; Carolyn A. Hutyra; Elizabeth P. Wahl; Vasili Karas; Janet L. Huebner; Virginia B. Kraus; Richard C. Mather III

Department of Orthopaedic Surgery, Duke University Health System, Durham, NC

Objective Methods Results Discussion

To determine if measurable osteoarthritis (OA) biomarkers exist in human synovial fluid of the hip joint and can they be used to predict the progression to OA.

Objective Methods Results Discussion

• Prospective study of • Areas of Interest: patients undergoing hip • Comparing biomarker concentrations between the two surgery for either primary diagnoses hip OA or femoroacetabular • Relationship between biomarker impingement (FAI). concentrations distribution and demographics (age, sex, BMI, • Radiographic Tonnis grade PROs, etc.) measured by three fellowship •Biomarkers trained hip surgeons. • CTX-II, sGAG, IL-1b, TNFa, • Intraoperative synovial fluid TSG-6, Neutrophil Elastase, collected from hip and COMP, MMP3plex, IL-6, CRP, analyzed for 20 potential OA CD14, NTx, dCOMP, TIMP-1, IL- biomarkers 8, VCAM-1, VEGF, CD163

1 Objective Methods Results Discussion

Exclusion criteria: • Secondary causes of OA – Infectious –AVN – Post-traumatic – Post-surgical – Autoimmune • Age <18

Statistical Methods: • Descriptive statistics including averages and standard deviations Copyright © 2013‐2018 Articular Engineering • Kappa scores for inter-rater reliability • Principle Component Analysis (PCA)

Objective Methods Results Discussion

79 patients included

54 patients with FAI 25 patients with primary OA

17/20 biomarker Tonnis grade BMI and Age MHHS and iHOT12 concentrations significantly significantly significantly significantly higher (worse) in higher in the OA higher (better) in different OA group group the FAI group 5

Objective Methods Results Discussion

Correlations between Principal Components and Biomarkers Biomarker* Component 1 Component 2 Component 3 Component 4 IL-1b (pg/mL) 0.904 -0.048 -0.080 -0.113 IL-6 (pg/mL) 0.876 -0.219 0.074 -0.068 IL-8 (pg/mL) 0.865 -0.149 -0.001 -0.121 TNFa (pg/mL) 0.654 -0.514 -0.255 0.135 VEGF-A (pg/mL) 0.751 -0.017 0.182 -0.493 CTXII (ng/mL) 0.723 -0.070 0.357 -0.113 TIMP-1 (pg/mL) 0.902 -0.029 0.203 -0.102 CRP (ng/mL) 0.608 -0.089 0.012 0.142 VCAM-1 (ng/mL) 0.906 0.085 -0.143 0.011 MMP-1 (pg/mL) 0.866 -0.018 -0.144 -0.173 MMP-3 (pg/mL) 0.497 -0.333 0.283 0.626 MMP-9 (pg/mL) 0.501 0.324 -0.649 0.062 NTx (BCE/mL) 0.666 0.388 0.143 -0.038 Inter-rater Agreement of Tonnis Grading (Tonnis Neutrophil Elastase (ng/mL) 0.520 0.570 -0.482 0.077 Grades of 0,1,2,3) Pairwise Between the Three Raters CD14 (ng/mL) 0.829 0.231 0.006 0.126 Comparison Weighted Kappa 95% CI CD163 (ng/mL) 0.739 0.100 0.103 0.414 Overall 0.82 (0.75, 0.89) TSG-6 Activity (ng/mL) 0.824 -0.125 -0.136 0.005 COMP (ng/mL) 0.246 0.354 0.600 -0.017 R1 : R2 0.77 (0.69, 0.84) dCOMP (ug/mL) -0.240 0.720 -0.012 0.064 R1 : R3 0.84 (0.77, 0.90) sGAG (ug/mL) 0.218 0.708 0.306 0.098 *Biomarkers were transformed using the log base‐10 function. R2 : R3 0.85 (0.79, 0.91) 6

2 Objective Methods Results Discussion

• Biomarkers show a difference • Ideally, biomarkers become a between the two diagnoses sensitive test in mild disease for – The profiles of the hip diagnoses diagnostic or prognostic purposes were different. Something about the biology is different between the two groups. • Create a risk prediction model to use as screening or preventative • Multivariable analysis would tool. better show which biomarker most predictive of diagnosis

Objective Methods Results Disclosures

3 2018 NCOA ANNUAL MEETING SATURDAY HANDOUTS Shoulder/Elbow Breakout

October 12-14, 2018 Kiawah Island Golf Resort, Kiawah Island, SC Shoulder Arthroplasty using Mini-Stem Humeral Components and a Lesser Tuberosity Osteotomy

Evan M. Guerrero, MD A. Jordan Grier, MD Michael P. Morwood, MD Roma A. Kankaria, MD Peter S. Johnston, MD Grant E. Garrigues, MD

Challenges in Shoulder Arthroplasty

• Subscapularis insufficiency – Most common cause of revision surgery in anatomic shoulder arthroplasty1 – Subtle deficiencies occur in up to 2/3 of patients postoperatively2

• Lesser tuberosity management: osteotomy, tenotomy, “peel” – Lesser tuberosity osteotomy (LTO): greater load to failure, less cyclic displacement compared to subscapularis tenotomy or peel3 – Allows monitoring of healing with standard radiographs

• Stem design: standard length, mini-stem, stemless Mini-stem humeral component Standard length humeral component – Mini-stem humeral components (MSHC): decreased bone removal, decreased stress shielding, ease of revision, and ease of treatment of peri-prosthetic fracture compared to standard-length stems

Methods

• Inclusion criteria: Consecutive patients age 18-99 who received anatomic TSA or HHA by one of the two senior authors using combined MSHC and LTO technique. Minimum 2 year clinical and radiographic follow up.

• Exclusion Criteria: Rotator cuff deficient shoulders, revision surgery, reverse total shoulder arthroplasty (RTSA)

• Postoperative protocol: sling for 6 weeks with well arm assisted ROM in the subscapularis safe zone (140° max forward flexion, 40° max external rotation), at 6 weeks sling discontinued, active ROM and stretching beyond safe zone begins

• Retrospective collection of data on consecutive patients including complications, ROM, pain, outcome scores, and radiographic analysis of 6 week postop and final X-rays

1 Results

• 75 shoulders, mean follow up 27.8 months (24-50 months)

• LTO healing: 67 (89.3%) uneventful healing, 5 (6.67%) failures, 1 (1.33%) fibrous union, 2 (2.67%) with osteotomies displaced >4 mm at 6 weeks

• 4/5 LTO failures required open repair, including one converted to RTSA.

• 4 (5.33%) stems subsided. • 1/4 loose, required revision • 3/4 were asymptomatic, not requiring treatment.

Discussion

• LTO failure fell within previously reported ranges, and early detection and repair resulted in similar functional outcomes compared to those with uneventful healing

• Implant loosening was uncommon at early follow up

• Technique recommendations: • Take care to preserve metaphyseal bone, standard-length stem should be available in case of an overaggressive LTO • LTO should not communicate with osteotomy of the humeral head • Strict adherence to designated postoperative ROM restrictions per protocol

• LTO and MSHC can be used together safely and effectively for anatomic TSA and HHA, achieving consistent pain relief and functional improvement

2 Canal‐Sparing Total Shoulder Arthroplasty

NCOA 2018 Kiawah, SC Tally Lassiter, MD, MHA Director, Duke Sports Medicine Wake County

Conflicts of Interest

I have the following relevant financial relationships with the manufacturers of any commercial products and/or providers of commercial services discussed in this CME activity.

Tornier: Research support My content will include reference to commercial products; however, generic and alternative products will be discussed whenever possible.

Why?

• Safer • Faster • Less stress shielding • Revisability

1 4

FDA IDE

• JBJS April 2016

Clinical & Radiographic Outcomes of SIMPLICITI Arthroplasty System – R.S. Churchill4

• Investigational device used as subject of a clinical study to collect data • Study required approval by FDA • IDE Publication published in JBJS Apr 2016 • Clearance was predicated by proving safety & effectiveness

2 IDE Study Design

• Single arm, 157 patient study • 14 investigational sites & 16 surgeons • Utilized a composite endpoint • Required 2‐year follow‐up

IDE Study Demographics5 • Age: Mean of 66 years (range, 37‐84) • Sex: 45 females and 112 (71%) males • Diagnoses ‐ 96%: Primary glenohumeral osteoarthritis ‐ 4%: Post‐traumatic • BMI: Mean of 31 (range, 18‐48) • The dominant limb was operated on in 53% of cases • 149 of the 157 completed 24 month visit (94.9%)

Constant Score Outcomes5

Components of Constant Score

100

0 Adjusted Raw Pain Score ADL Score ROM Score Strength Constant Constant Baseline 24 Month Score

91.4% of subjects had Results similar to adjusted CS >85 historical controls

3 Radiographic Outcomes Summary5

3 Independent Radiographers Conclusions: • No radiolucent zones • No evidence of component migration • No subsidence • No osteolysis • No loosening of humeral components

Revision/Explant Surgery5

Surgery 2 wk 3 mo 6 mo 12 mo 24 mo SIMPLICITI Revision/Explant 001A 113B (cumulative)

A Infection (6 weeks) B Rotator cuff weakness (14 months) and aseptic glenoid loosening (18 months)

Summary: • No intraoperative complications • No system‐related adverse events • 3 Postoperative revisions ‐ 1 Replaced humeral head (Infection) ‐ 1 Subscapularis failure ‐ 1 Aeseptic glenoid loosening

Secondary Outcomes5

Simple Shoulder Test (SST) American Shoulder and

12 Elbow Surgeon Score (ASES)

10 100

8 80

6 60

4 40

2 20

0 0 Baseline 3 Month 6 Month 12 Month 24 Month Baseline 3 Month 6 Month 12 Month 24 Month Improved from 4.3 to 10.8 Improved from 38.2 to 91.9

Pain (Visual Analog Scale) Range of Motion 7 200 6 150 5 4 100

3 50 2 0 1 Baseline 3 Month 6 Month 12 Month 24 Month 0 Scapular Plane, Active (degrees) Baseline 3 Month 6 Month 12 Month 24 Month Internal Rotation, Active (degrees) Improved from 5.9 to 0.5 External Rotation, Active (degrees)

4 SIMPLICITI Surgical Technique Overview 7 simple steps:

SIMPLICITI Shoulder System Summary • Younger, active patient population (<55) who will need TSA growing 333% through 2030 • Canal sparing systems have demonstrated: • Reduction in blood loss and OR times6 • Reduction in risk of surgical and postoperative fractures5 • Reduction in hospital length of stay6,10,11 • Reduction in 90‐day readmission rates9,12 • SIMPLICITI has demonstrated results similar to traditional TSA in parallel to reduced complications and adverse events9 • Revisability

Sub‐scap Management

• Tenotomy • Add anchors

5 Contraindications

• Soft bone

Advantages

• Mal‐unions

Future

• Stemless Reverse

6 Canal‐Sparing Total Shoulder Arthroplasty

NCOA 2018 Kiawah, SC Tally Lassiter, MD, MHA Director, Duke Sports Medicine Wake County

7 1 Outcomes of Subacromial Balloon Spacer Implantation for Massive and Irreparable Rotator Cuff Tears: A Systematic Review

RUSSELL K. STEWART, BA STEPHEN A. PARADA, MD NIKHIL N. VERMA, MD BRIAN R. WATERMAN, MD

Disclosures 2

• No Financial Disclosures • No Conflicts of Interest

Background 3

. Massive rotator cuff tear . Irreparable rotator cuff tear

. Acromiohumeral distance

Saupe N, Pfirrmann CWA, Schmid MR, Jost B, Werner CML, Zanetti M. Association Between Rotator Cuff Abnormalities and Reduced Acromiohumeral Distance. American Journal of Roentgenology. 2006;187(2):376-382.

1 Subacromial Balloon Spacer 4

. Produced by OrthoSpace . Approved in Europe since 2010 . Investigational exemption for use in the US . Inflatable balloon composed of biodegradable copolymer

. Reduce friction . Increase ROM before impingement

Methods 5

. Literature search in April 2018 . MEDLINE, Cochrane, Google Scholar . Keywords - Subacromial balloon - Biodegradable spacer - Massive rotator cuff tear - Humeral head migration - Irreparable rotator cuff tear

. All references within studies were cross-referenced for inclusion if missed by initial search

Methods 6 Records identified through database search Duplicates N = 1440 N = 149

Records after duplicates removed N = 1291 Excluded - Specific device N = 1252 not studied

Potentially relevant studies screened Excluded N = 39 - No original data N = 27

Studies included in analysis N = 12

2 Results 7

 10 clinical studies (level 4 evidence)  266 shoulders (259 patients)  Mean age 68.0 years old  Marginal male predominance (51.6%)  Mean follow-up 22.1 ± 13.4 months (min f/u 12 months)

Results 8

 All patients underwent at least debridement + balloon implantation  130 shoulders had concomitant procedures performed  Biceps tenotomy (72 shoulders)  Partial repair (21 shoulders)  Biceps tenotomy + bursectomy + acromioplasty (13 shoulders)  Biceps tenotomy + bursectomy (24 shoulders)

3 Complications 10

 5 patients (1.9%) experienced complications  Transient neuropraxia of lateral antebrachial cutaneous nerve  Superficial wound infection  Deep wound infection *  Balloon migration *

* Required subsequent surgery for balloon removal

Discussion 11

 Subacromial balloon spacer implantation has demonstrated effectiveness in pain reduction and functional improvement for patients with massive and irreparable rotator cuff tears

 Particular advantages:  Low complication rates (1.9%)  Extended surgery and/or general anesthesia may be contraindicated in patients who have massive rotator cuff tears  If the balloon does not provide sufficient results, all salvage procedures remain possible

Discussion 12

 Potential confounders  Is clinical benefit caused directly by balloon?  What role did concomitant procedures play in clinical outcome?

 Pain reduction and functional persist beyond time of balloon disintegration  Reason is unclear

 Further studies are recommended to vet the effectiveness of balloon implantation compared to other minimally invasive techniques

4 Techniques and Fixation of Olecranon Osteotomy: A Systematic Review

Emily Jewell MD, Shawn Daniel Feinstein MD, Sarah T. Wright MLS, Reid Wilson Draeger MD

Background • Objective: » to conduct a systematic review of the available literature to better characterize the complications associated with types of osteotomies and various fixation constructs of the olecranon • Source: » Papers from the following electronic databases from inception to June 1, 2018: Pubmed, Cochrane, EMBASE.com, CINAHL via EBSCO, and Web of Science • Search terms: » “olecranon” and variations of “osteotomy” • Covidence Systematic Review software » Tracks each step from each individual reviewer of entire review process 2

Methods • Inclusion Criteria: » adult clinical study, transverse or chevron olecranon osteotomy, fixation construct used to repair the osteotomy stated, minimum average follow-up 12 months • 35 Studies included with total of 1,154 patients

1 Outcomes

*denotes statistical significance using chi-squared test and p-value <0.05 4

Outcomes

Conclusions • Nonunion » transverse osteotomy (8.3%; 6 of 72) higher than chevron osteotomy (2.3%; 29 of 1038) (p < 0.01) » Highest in cancellous screw alone at 10.3% (4 of 39) • Implant failure requiring revision » transverse osteotomy (8.3%; 6 of 72) was higher than chevron osteotomy (2.7%; 33 of 1038) (p = 0.022) » Highest in cancellous screw alone at 7.7% (3 of 39) • Implant removal » 23.9%% (21 of 88) in the plate group

2 My experience with computer navigation for shoulder arthroplasty

Gregory S. Bauer MD NCOA 2018

Disclosure

• Consultant for Exactech • Teach Med Ed Classes • No Royalties

My background

Neer Shoulder Fellowship 18th year in practice UNC Wayne Hospital-300 beds Around 1000 shoulder arthroplasties 70/year 16 Navigation cases so far

1 First thing I learned

I am not as good as I thought

Glenoid Implantation Variability • Iannotti et al. demonstrated that the angular accuracy associated with the use of free-hand glenoid instruments for pin placement exceeded ± 10° in version & inclination, and is also offset.

•.

Glenoid Implantation Variability • Use of PSI resulted in improved precision, but was still associated with ±7°in version & inclination.

2 Glenoid Implantation Variability • Meta-analysis by Sadoghi et al. demonstrated that the average error in glenoid retroversion with standard instruments and computer navigation was 10.6° & 4.4°, respectively.

• Thus, navigation was associated with a 6.2° improvement in accuracy. 7

68 yo internist

• Very tight •ER 0 • FE 110 • Intact cuff

68 yo internist

3 68 yo internist

Pre-op planning is a must

•GPS • Blueprint-Tornier • Depuy •Arthrex

68 yo internist plan

4 68 yo internist plan

68 yo internist plan

GPS Shoulder intraop

• CT based, real-time view of: – Glenoid Version/Inclination – Glenoid Position – Reaming depth – Screw placement

5 68 yo internist post op

Does it increase OR time for aTSA?

• 12 cases of each

• Mean aTSA difference = 6 min

• aTSA with standard instruments = 70 min

• aTSA with navigation = 76 min 17

Does it increase OR time for rTSA? • 28 cases of each

• Mean rTSA difference = 10 min.

• rTSA with standard instruments = 64 minutes

• rTSA with navigation = 74 minutes 18

6 Take home points

• Navigation improves accuracy • Preop planning is very useful • Short learning curve • Not much extra OR time • A very nice tool for your tool box

One more case

• 46 yo F BMI is also 46 • Over 50 dislocations since age 18 • Never had insurance • 6 months ago became insured • Scope bankart. Pics show grade 4 changes • Dislocated multiple times after surgery • Told needs shoulder specialist

7 22

8 25

Thank you

9 COMPUTER ASSISTED SHOULDER ARTHROPLASTY

NCOA 2018 Kiawah, SC

Tally Lassiter, MD, MHA Director, Duke Sports Medicine Wake County

CONFLICTS OF INTEREST

I have the following relevant financial relationships with the manufacturers of any commercial products and/or providers of commercial services discussed in this CME activity.

Tornier: Research support

My content will include reference to commercial products; however, generic and alternative products will be discussed whenever possible.

1 CAVEAT NO METAL

)

UNDERSTAND WHY?

• “The Challenge” • The glenoid component accounts for 24% of all complications in anatomic arthroplasty • Asymptomatic radiographic lucent lines appear at rate of 7.3%/yr • Symptomatic glenoid loosening

1. Papadonikolakis A et al. Failure of the glenoid component in anatomic total shoulder arthroplasty: a systematic review of the and revision rates of 1.2 and English‐language literature between 2006 and 2012. J Bone Joint Surg Am. 2013 Dec 18;95(24):2205‐12. .8%/yr 5

WALCH GLENOID CLASSIFICATION

2 UNDERSTAND WHY?

DOES IT MATTER?

• FEA demonstrated >10 degrees of retroversion significantly increased micro motion at bone cement interface Farron et al.

• Radiographic study in 66 shoulders, 3.8 yr FU, glenoids >15 degrees of retroversion 45% radiolysis around central peg compared to 23% in <15 degrees Ho et al.

1. Farron A et al. Measurements of three‐dimensional glenoid erosion when planning the prosthetic replacement of osteoarthritic shoulders. Bone Joint J. 2014 Apr;96‐B(4):513‐8. 2. Ho JC et al. Glenoid component retroversion is associated with osteolysis. J Bone Joint Surg Am. 2013 Jun 19;95(12):e82. 7

UNDERSTAND WHY?

• Is 2D CT as accurate as 3D? • 3D templating improves the surgeons ability to place the glenoid implant in the desired location. Iannotti et al.

• Reformatted 2D measurements are not as accurate as 3D measurements • Sig. difference in glenoid retroversion 2D v. 3D • 15% patients indicated for different approach Werner et al. 8

UNDERSTAND WHY?

Are we as good as we think?

3 UNDERSTAND WHY?

STANDARD 3D Planning PSI INSTRUMENTATION

Iannoti et al. Walch et al. 10

“YOU HIT HOME RUNS NOT BY CHANCE, BUT BY PREPARATION.”

-ROGER MARIS

HOW DO SOME USE BLUEPRINT™?

1. Clinical 2. Patient Experience 3. Marketing

4 HOW TO USE BLUEPRINT?

• Plan all cases with BLUEPRINT • Accurate measurement of pathologic anatomy • Identification of relevant bony anatomy/landmarks • Cysts • Severe bony deficiency • Vault perforations • Avoid hanging glenoid • Intra op confidence • Implant sizing/availability- efficiency for your OR • Backside ROC • Preservation of subchondral bone 13

APPROACH TO GLENOID

• Version & Inclination Correction: <10 degrees • Adequate backside bony coverage: >80% • Preservation of subchondral bone • Avoid vault perforation

• Get central peg in good bone 14

HOW TO USE BLUEPRINT?

• Should you perform a Hemi vs TSA vs RSA? • How much retroversion can I correct & what are the consequences? • Is a standard or augmented glenoid or baseplate better for the patient? • Which glenoid solution preserves the most

bone? 15

5 HOW DO I USE BLUEPRINT?

Should you order a guide? • How easily can I replicate the optimal plan with standard instrumentation? • Is my eye more accurate than a PSI guide? • How good is my pin positioning on worn glenoids under direct visualization alone?

HOW DO I USE BLUEPRINT?

• Indications for Guide: • Native anatomy or deformity that compromises vault with potential for peg perforation • Optimizing positioning of central peg for bony ingrowth • B2 glenoid • Greater than 10 degrees of version correction • Augmented prosthesis 17

HOW I USE BLUEPRINT

6 1) Skeletonize Ant/Post Glenoid 2) Confirm adequate foot seating 3) Pass pin thru far cortex 4) Palpate pin in “Matsens point”

68YO RHD WATERMAN

• 1-2 yrs of increasing pain and shoulder dysfunction. Failed conservative tx. No previous surgeries. • PE • FE=100 ER=25 IR=buttock w/crepitation • Preserved supra/infra strength, difficult to assess BP w int rotation contracture • Glenohumeral crepitation

7 BLUEPRINT OPENING MEASUREMENTS

AEQUALIS™ PERFORM™ GLENOID- CORRECTIVE REAMING

AEQUALIS PERFORM GLENOID

8 AEQUALIS™ PERFORM™+ GLENOID

REVIEW OF PLAN

ANOTHER OPTION?

9 28

CONCLUSION

• Confidence • Accuracy • Execution

Matsen’s Point = glenoid centering point

10 WALCH’S GOLDEN RULES OF TSA

•80% coverage •10 degrees retroversion •10 degrees superior inclination

INITIAL CT

11 3 SCENARIOS

WEDGE

50% RADIOGRAPHIC LOOSENING AT 10 YEARS

Results of a convex‐back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow‐up greater than 5 years. Walch et al; JSES (2011) 20, 385‐394.

• Sites with most aggressive reaming had most loosening Courtesy of G. WALCH • Takeaway: Bone preservation is key to longevity

12 Enhancing Glenoid Bone Preservation

• Compared to 2D imaging, “Using 3D imaging technique…improved significantly the placement of the glenoid component…”1

• BLUEPRINT™ 3D Planning + PSI provides: •Real‐time 3D virtual implantation and decision making of the best fit implant curvature, size and position

•Automatic calculations of version & inclination

•Reaming depth measurement

•Glenoid Implant seating coverage visualization

•Replication of virtual plan using PSI Guides (optional)

1. Iannotti, J, etal. Three‐dimensional preoperative planning software and a novel information transfer technology improve glenoid component positioning. J Bone Joint Surg Am May 7;96(9):e71.

Improved Implant Accuracy

PSI guides translate virtual plan to the OR Metal Guides Rigidity, Stability, and Rotation Control Standard 1 2 Instrumentation

1. lannotti, J, etal. Three‐dimensional preoperative planning software and a novel information transfer technology improve glenoid component positioning. J Bone Joint Surg Am May 7;96(9):e71. 2. Walch, G, etal. Patterns of Loosening of Polyethylene Keeled Glenoid Components After Shoulder Arthroplasty for Primary β Osteoarthritis. J Bone Joint Surg Am 2012;94:145‐50

Everyday Planning Capability

You’re in control • Blueprint resides directly on your computer for everyday planning • Automated software 3D reconstruction • Plan in seconds: No uploading CT scans through a company • Guides are optional

13 Summary: Improving Glenoid Survivorship

CLINICAL CHALLENGE SOLUTIONS

Bone‐Preserving Glenoid Design OVER‐REAMING Implant systems that adapt to the wide variety of glenoid curvatures

Virtual 3D Planning & Implantation INACCURATE Reliable, accurate & convenient tool for PLANNING TOOLS determining optimal treatment and implant positioning

INACCURATE Patient‐Specific Instrumentation IMPLANT Guide for accurately replicating POSITIONING pre‐operative plan β β

THE BLUEPRINT™ DIFFERENCE: SPEED & PLAN OPTIMIZATION

Automated software 3D reconstruction (seconds) Engineer-driven 3D reconstruction (days) Immediate surgeon planning Delayed planning access

New BLUEPRINT™ Platform Additions

PERFORM+ and Anatomic & Reversed Plan Comparison PERFORM REVERSED Planning Humeral Planning

Compare up to 3 plans at a time

14 New BLUEPRINT™ Platform Additions

Reversed Range‐of‐Motion & Bony Impingement Identification

MANY WAYS TO SKIN A CAT

COMPUTER ASSISTED SHOULDER ARTHROPLASTY

NCOA 2018 Kiawah, SC

Tally Lassiter, MD, MHA Director, Duke Sports Medicine Wake County

15 2018 NCOA ANNUAL MEETING SATURDAY HANDOUTS General Interest Breakout

October 12-14, 2018 Kiawah Island Golf Resort, Kiawah Island, SC Tumor for the Generalist

Cynthia L. Emory, MD, MBA Associate Professor and Vice Chair, Department of Orthopaedic Surgery

Disclosures

Disclosures listed on AAOS website, none related to this talk.

Wake Forest Baptist Medical Center

Objectives

1. Identify which bone tumors should have further evaluation and referral 2. Identify which soft tissue tumors should have further evaluation and referral 3. Appropriate advanced imaging for tumors 4. Identify key points in history or exam that suggest malignancy

Wake Forest Baptist Medical Center

1 Bone Tumors

Wake Forest Baptist Medical Center

Bone Tumors - Presentation • Musculoskeletal complaint • Dull, aching pain, antecedent pain • Progressive, perhaps starting with activity- related pain and progressing to constant • Night pain • +/- mass • History of cancer? If you don’t ask, they won’t tell you • Risk factors for cancer? If you don’t ask, they won’t tell you Wake Forest Baptist Medical Center

Bone Tumors – Physical Exam

• Overlying skin changes • Associated soft tissue mass • Adenopathy • If > 40 yrs old , consider possibility of metastatic disease • Breast, prostate, abdominal, thyroid exam

Wake Forest Baptist Medical Center

2 Case Presentation

• 66 yo female with L knee pain x 6 months • Initial evaluation with local orthopaedic surgeon (Dec 2015) • Initial tx: CS injection, OTC meds

Wake Forest Baptist Medical Center

Case Presentation

• Initial (+) response to CS injection • Pain returns 6 weeks later (Feb 2016) • PT, brace • Continues to have pain • Decision for TKA made (April 2016)

Wake Forest Baptist Medical Center

3 Case Presentation

• Patient calls office in May due to worsening knee pain and inability to bear weight • Surgery scheduled for June • Presents for MRI (patient matched TKA planned)

Wake Forest Baptist Medical Center

Hmmmmm…. Now what?

Wake Forest Baptist Medical Center

June 2016

Wake Forest Baptist Medical Center

4 Wake Forest Baptist Medical Center

Learning Points

• It’s not always just arthritis • Opportunity for xrays and/or office visit when patient called with progressive pain and inability to bear weight? • You’re responsible for the imaging you order

Wake Forest Baptist Medical Center

Case #2 February 13, 2017

60 yo female with R hip pain

Wake Forest Baptist Medical Center

5 February 13, 2017 Case #2

Wake Forest Baptist Medical Center

February 28, 2017

Cor T1

Wake Forest Baptist Medical Center

Axial T1

Wake Forest Baptist Medical C enter

6 STIR

Wake Forest Baptist Medical Center

March 21, 2017 –2 weeks post op

Wake Forest Baptist Medical Center

April 27, 2017 –6 weeks post op

Wake Forest Baptist Medical Center

7 June 2017 (3 months post‐op)

Wake Forest Baptist Medical Center

Shortness of Breath – July 4, 2017

Wake Forest Baptist Medical Center

July 21, 2017 –4 months post‐op

Wake Forest Baptist Medical Center

8 Wake Forest Baptist Medical Center

Where to Start • Radiographs • AP and lateral minimum • Bone scan • Occult fractures or malignancies • Can be falsely negative • Ultrasound • Cystic versus solid • Hematomas, popliteal cysts •Kids

Wake Forest Baptist Medical Center

Where to Start

•MRI • Useful for assessing extraosseous extent of tumor or subclinical evidence of disease • Best for soft tissue tumors (WWO gad) • CT scan • Helpful for evaluating matrix and bone architecture/erosion • Helpful for chondroid tumors

Wake Forest Baptist Medical Center

9 Case #3 – 65 yo Left Hip Pain

Lesion?

Wake Forest Baptist Medical Center

Case #3 – Left Hip Pain

Wake Forest Baptist Medical Center

Metastatic Bone Disease - Lung

Wake Forest Baptist Medical Center

10 Metastatic Bone Disease – Renal Cell

Single met – resect and reconstruct; consider pre‐op embolization

Wake Forest Baptist Medical Center

How Do You Know It’s Metastatic?

• Need tissue diagnosis • Primary site and bone site • Beware of “late metastasis”

Wake Forest Baptist Medical Center

Soft Tissue Tumors

Wake Forest Baptist Medical Center

11 Soft Tissue Tumors - Presentation

• Painful or painless mass that is enlarging or stable for a period of time • Often associated with (but unrelated to) an injury

Wake Forest Baptist Medical Center

Soft Tissue Tumors – Physical Exam

• Large, small • Painful, painless • Firm, soft • Fixed, mobile • Fluid-filled, solid

Wake Forest Baptist Medical Center

Who Needs a Work-Up?

•Newmass • Enlarging mass •> 3cm • Firm, deep mass • Advanced imaging prior to procedures

Wake Forest Baptist Medical Center

12 Thank You

Wake Forest Baptist Medical Center

13 CLINCALLY RELEVANT MODULATORS OF SYNOVIAL CELL COUNT IN NATIVE JOINT SEPTIC ARTHRITIS 1 D. Landry Jarvis Wake Forest Baptist Medical Center Orthopedic Surgery PGY5

Other Contributors: Johannes Plate MD, Hunter Yancey MS, Max Langfitt MD

TWO ARM STUDY

Crystalline Immunosuppresion Arthropathy

OUTLINE

 Background  Method  Demographics  Results  Analysis  Conclusion and Future Projects

1 BACKGROUND 4 What Does the Literature Say?

EPIDEMIOLOGY AND FINANCIAL COST

 In the U.S., septic arthritis was responsible for 16,382 ED visits in 2012 (0.01%).  83% of the patient with septic arthritis were hospitalized.

16,382 ED visits 83% in the U.S. $$$ annually for hospitalized septic arthritis.

Or is gout? ¢

Singh, Jasvinder A., and Shaohua Yu. "Septic arthritis in the Emergency Departments in the US: A National Study of healthcare utilization and time‐trends." Arthritis Care & Research 5 (2017).

FIFTY-THOUSAND

 2007 Meta-analysis (14-studies) suggested that the likelihood ratio of septic arthritis significantly increased with cell counts greater than 50,000 and polys > 90% (n=6262)

 Margaretten, Mary E., et al. "Does this adult patient have septic arthritis?." Jama 297.13 (2007): 1478-1488.

 However up to 1/3 of culture positive septic joints have synovial WBC < 50k. (n=73)

 Li, Siu Fai, et al. "Laboratory tests in adults with monoarticular arthritis: can they rule out a septic joint?." Academic emergency medicine 11.3 (2004): 276-280.

 Other studies in appropriately filtered populations have suggested CRP and synovial lactate to be more helpful in distinguishing a true septic joint from gout or other inflammatory conditions  Lenski, Markus, and Michael A. Scherer. "Analysis of synovial inflammatory markers to differ infectious from gouty arthritis." Clinical biochemistry 47.1 (2014): 49-55.

 Roberts, John, Eric Schaefer, and Robert A. Gallo. "Indicators for 6 detection of septic arthritis in the acutely swollen joint cohort of those without joint prostheses." Orthopedics 37.2 (2014): e98-e102.

2 COEXISTENCE OF GOUT AND SEPTIC JOINT?

•Having a medical history of gout correlates with an 2x increased chance of developing a septic joint. Coorelation (n=400,000) •Lim, Sian Yik, Na Lu, and Hyon K. Choi. "Septic arthritis in gout patients: a population-based cohort study." Rheumatology 54.11 (2015): 2095-2099.

but

• Mainly just case reports. • At a large university hospital in South Taiwan only 14 case in 20 years. •Weng, C. T., et al. "Rare coexistence of gouty and septic arthritis: a report of 14 cases." Clin Exp Rare Rheumatol 27.6 (2009): 902-6. • <2% of gouty aspirates found to be culture positive. (n=265) •Shah, Kaushal, et al. "Does the presence of crystal arthritis rule out septic arthritis?." The Journal of emergency medicine 32.1 (2007): 23-26. 7

BACTERIOLOGY OF SEPTIC ARTHRITIS

MRSA/MSSA 57% Coag Neg Staph 8% All others < 5%

 Kennedy, Nicholas, et al. "Native joint septic arthritis: epidemiology, clinical features, and microbiological causes in a New Zealand population." The Journal of rheumatology 42.12 (2015): 2392-2397. 8  Lim, Sian Yik, Na Lu, and Hyon K. Choi. "Septic arthritis in gout patients: a population-based cohort study." Rheumatology 54.11 (2015): 2095-2099.

 Dubost, Jean-Jacques, et al. "Three-decade trends in the distribution of organisms causing septic arthritis in native joints: single-center study of 374 cases." Joint Bone Spine 81.5 (2014): 438-440.

METHODS 9 Retrospective Chart Review

3 PATIENT SELECTION

Data request for every IRB approval patient with a for retrospective 652 patients synovial cell chart review count lab value from 2013-2015.

INCLUSION/EXCLUSION CRITERIA

Adult Lacking any of the 3 labs: Inclusion Native joint crystals culture Aspiration performed in ED or cell count

inpatient setting Exclusion

275 11

DATA EXTRACTED

Aspiration Immuno- Joint DM Team compromised

Tobacco Fever Effusion WBC Status

Synovial Cell ANC CRP ESR Count

Polys Crystals Gram stain Culture*

4 RESULTS 13 Raw Data

DEMOGRAPHICS

Joint N percentage Avg. range Knee 189 69.0% Age 59.13 18-97 Ankle 23 8.4% Elbow 14 5.1% Wrist 18 6.6% Male 180 65.6% Shoulder 10 3.7% Female 95 34.4% Hip 14 5.1% Left 140 50.7% MTP 5 1.8% Right 135 49.3% other 3 1.1%

DATA

Cell Count > 50k 6

23 17 2 86 0 9 Positive Crystals Positive Culture

5 DATA

Cell Count > 50k 132 6

23 17 2 86 0 9 Positive Crystals Positive Culture

DATA

Cell Count > 50k 6

23 17 2 86 0 9 Positive Crystals Positive Culture

DATA

Cell Count > 50k 6

23 17 2 86 0 9 Positive Crystals Positive Culture

6 DATA

Cell Count > 50k 6

23 17 2 86 0 9 Positive Crystals Positive Culture

BACTERIA

Bacteria n Percentage of total MSSA 12 42.9% MRSA 7 25% Coagulase Neg Staph 2 7.1% E. Coli 2 7.1% Strep 2 7.1% Pseudomonas 2 7.1% E. Faecalis 1 3.6%

ANALYSIS 21 The meaning of the numbers

7 ANALYSIS

Positive Negative Sensitivity 67.9% All total Specificity 88.2% culture culture CC≥50 19 29 48 LR+ : 5.78; 95% CI [3.77-8.85] LR- : 0.36; 95% CI [0.21-0.63] CC<50 9 218 227 total 28 247 275 PPV = 39.6%; 95% CI [29.96%-50.09%]

Positive Negative Sensitivity 65.4% No Crystals total culture culture Specificity 95.7% CC≥50 17 6 23 LR+ : 15.04; 95% CI [6.55-34.52] CC<50 9 132 141 LR- : 0.36; 95% CI [0.21-0.61] total 26 138 164 PPV = 73.9%; 95% CI [55.24%-86.67%]

Positive Negative Sensitivity 100% Crystals total culture culture Specificity 78.9% CC≥50 2 23 25 LR+ : 4.74; 95% CI [3.3-6.81] LR- : 0; 95% CI [0] CC<50 0 86 86 22 total 2 109 111 PPV = 8%; 95% CI [5.7%-11.11%]

FURTHER ANALYSIS

Negative 50K Positive culture total culture Crystals 2 23* 25 No Crystals 17 6 23 total 19 29 48

Odds Ratio: 0.03 CI [0.0055-0.1712] p value: 0.0001

Positive Negative 50K total culture culture Crystals 2 23* 25 All patients 19 29 48 *7 of these 23 went to the OR for I&D

Odds Ratio: 0.13 CI [0.0280-0.6294] 23 p value: 0.011

CONCLUSIONS

 Simply ignoring the presence of crystals in patients with elevated cell counts will result in numerous unneeded operations and admissions and place undue physical stress on patients unecessarily.

 As literature has previously described, co- infection and gout is exceedingly rare.

8 FUTURE EFFORTS

 Continue to accumulate data to strengthen statistics within crystalline arthropathy arm.  Determine a new cell count value (or another lab) that is more accurate for use in patients with crystalline arthropathy.

 Isolate the immunosuppressed group and analyze the data in order to determine recommendations for handling synovial cell count in that population.

9 The Orthopaedic Destination Motion Sparing Techniques for Cervical Spine Disorders

Venu M. Nemani, MD, PhD Cervical & Reconstructive Spine Surgeon Raleigh Orthopaedic Clinic [email protected]

NO relevant financial conflicts of interest to disclose.

Goals

•Understand the indications (and contraindications) for motion sparing procedures in the cervical spine

1 When can we avoid a cervical fusion?

When can we avoid a cervical fusion?

Cervical disc replacement vs ACDF

Best Indication •Soft disc herniation without degenerative disease

Contraindications •Cervical kyphosis •Instability on flexion/extension •Severe disc collapse (< 3mm persistent disc space) •Facet arthrosis at operative level

2 Cervical disc replacement vs ACDF

Pros •Decreased incidence of adjacent segment degeneration •Superior outcomes in carefully selected patients compared to ACDF, especially in re-operation rate

Cons •Unclear long term sequelae of wear debris near spinal cord, nerve roots •Longevity of implant bearing surface?

Laminoplasty vs multilevel fusion

Indications •Multilevel spinal stenosis causing cervical myelopathy with neutral to lordotic alignment

Contraindications •Cervical kyphosis •Cervical instability •Stenosis requiring complete resection of the C2 or C7 spinous processes

Laminoplasty vs Multilevel fusion

Pros •Motion sparing procedure •No risk of pseudarthrosis •Largely equivalent improvement in myelopathy scores

Cons •Technically more challenging •Risk of post-operative kyphosis (likely technique dependent)

3 Thank You!

Venu M. Nemani, MD, PhD Raleigh Orthopaedic Clinic Cell: 415‐902‐1203 Email: [email protected]

4 2018 NCOA ANNUAL MEETING SATURDAY HANDOUTS Sports Breakout

October 12-14, 2018 Kiawah Island Golf Resort, Kiawah Island, SC The Financial Burden Associated with Multiple Shoulder Dislocations and the Potential Cost- Savings of Surgical Stabilization Shea Comadoll, BS; Douglas Jarvis, MD; Hunter Yancey, BS; Benjamin Graves, MD

Benjamin Graves (PI): consultant for Depuy/Mitek I and the other co-authors have nothing to disclose. Wake Forest Baptist Medical Center

Purpose/Hypothesis ● Shoulder dislocation is a potentially costly problem. ● Incidence rates vary from 23.1 to 23.9 per 100,000 person-years.1 ● Recurrent instability following a first-time shoulder dislocation may exceed 26%1 ● First-time dislocators treated with shoulder stabilization surgery have redislocation rates 5-10%2

Purpose: The goal of this study is to help guide healthcare resource allocation through economic evaluation of the costs of shoulder dislocation and operative versus non- operative treatment options.

Hypothesis: While a potential larger cost on the front-end, stabilization surgery may in fact decrease the overall healthcare burden of managing a patient with multiple shoulder dislocations compared to non-operative treatment.

1. Olds, M., et al. "Risk factors which predispose first-time traumatic anterior shoulder dislocations to recurrent instability in adults: a systematic review and meta-analysis." British journal of sports medicine (2015): bjsports-2014.

2. An, Vincent Vinh Gia, et al. "A systematic review and meta-analysis of clinical and patient-reported outcomes following two procedures for recurrent traumatic anterior instability of the shoulder: Latarjet procedure vs. Bankart repair." Journal of Shoulder and Elbow Surgery 25.5 (2016): 853-863.

Wake Forest Baptist Medical Center 2

Materials and Methods

• Retrospective study: patients with shoulder dislocation who presented to an ED at a level 1 trauma center in 2016. • Chart review performed to determine: • Demographics • Dislocation history • Injury and treatment specifics (mechanism, neurovascular status, sling, radiographs) • Anesthesia for reduction • Prior or scheduled shoulder surgery • Financial Department assisted with: • Determining average cost of ED presentation for shoulder dislocation based on anesthesia used for reduction • Direct hospital cost of shoulder stabilization procedures (Laterjet and Bankart repair) • Using this data a cost-benefit analysis was constructed to assess shoulder stabilization surgery as a preventative measure of future ED visits/costs as compared to costs incurred after subsequent shoulder dislocations.

Wake Forest Baptist Medical Center 3

1 Results Injury and Treatment Information

Fall: 45 (43.3%) • 104 unique individuals presented to MVC: 8 (7.7%) Cause of dislocation Direct blow: 3 (2.9%) the ED Pedestrian Struck: 3 (2.9%) • 63% Male and 37% female Other: 45 (43.3%) Bankart lesion: 79 (75.9%) • Average age 42 Associated injuries Hill-Sachs deformity: 66 (63.5%) • Most common age range was 21-30 GT fracture: 14 (13.5%)

• Average number prior ED visits for Intra-articular Block: 51 (49%) Anesthetic for reduction Conscious Sedation: 41 (39.4%) dislocation: 3.1 General Anesthesia: 9 (8.7%) • Average reported number prior dislocations: 3.5 • Average time in ED: 5.5 hrs • Average cost ED shoulder dislocation: • Orthopaedics Consult: 33 (31.7%) $2,207 • not taking into account the individuals who underwent general anesthesia to aid with reduction. • Average cost shoulder stabilization procedure: $7,807.

Procedure Average Cost

ED Treatment of Shoulder Dislocation w/o $973 Conscious Sedation

ED Treatment of Shoulder Dislocation with $3,744 Conscious Sedation

Laterjet Procedure $7,852

Bankart repair $7,784 Number of Patients

Wake Forest Baptist Medical Center 4

Conclusion

• In 2016 at a single Academic Institution the cost of treating: • shoulder dislocations in the ED: >$200,000 • repeat dislocators was >$88,280 • those with 3 or more dislocations >$42,600 • Prevention of an ED visit for a recurrent shoulder dislocation saves on average $2,207 starting after 2-3 “prevented” future visits • In patients at a high risk of recurrent instability, these data suggest there may be cost-savings benefits from early stabilization surgery.

• Limitations: • retrospective design • inability to track patient visits to ED not within our hospital system • subset of patients with multidirectional instability or secondary gain, such as malingering, who would not be helped with a simple stabilization surgery, could not be excluded from the data, potentially overvaluing the cost savings of a surgical operation.

• Future Directions: • effects of orthopaedic consult and orthopaedic follow up on the occurrence of repeated dislocations • frequency of patients being offered and receive stabilization procedures

Wake Forest Baptist Medical Center 5

Thank You!

Wake Forest Baptist Medical Center

2 The Role of Femoral Nerve Blocks for Anterior Cruciate Ligament Reconstruction – A Change in Practice M. Leslie Golden, MD Robin Leopold, MD Ty Bullard, MD Jeffrey Spang, MD University of North Carolina Department of Orthopaedics

Risk of Femoral Nerve Blocks

• AJSM 2014 » Luo et al compared 6 month isokinetic strength in 124 pediatric post op ACL-R » FNB group -statistically significant strength deficits and delayed RTP vs. control

• Arthroscopy 2017 » Swank et al -systematic review to compare FNB to multimodal anesthesia » Suggestive that FNB causes deficit of quad strength up to 6 mo post-op with uncertain impact on return to sport

Efficacy of Femoral Nerve Block Alternatives • Arthroscopy 2018 » Kurosaka et al randomized 129 patients to periarticular injection or FNB after ACL-R » Found significantly better pain control (VAS scores) and decreased opioid use in periarticular injection group • AJSM 2016 » Secrist et al -systematic review of randomized controlled trials looking at pain management after ACL-R » Found regional nerve blocks and intra-articular injections efficacious » Early mobilization and multi-modal pain regimens reduce opioid consumption 3

1 Methods

• Retrospective chart review ACL-R July 2016-March 2018 • Patients who did not receive a preoperative block were offered one postoperatively • Patient factors analyzed: » age, gender, BMI, pre-operative narcotic use, smoking status • Operative factors analyzed: » graft type, meniscus surgery, chondral surgery, revision, > 1 ligament surgery

Results

• 172 ACL-R qualified with 56 patients (32.5%) requiring a post-op FNB • A statistically higher proportion of females(48.7%) (37/76) than males(19/96) required post-op FNB blocks (p<.0001) • Average age of FNB 27.6 years versus no block 24 years (p=0.01) • Allograft patients (50%) more likely to need FNB than autograft patients (26.9%) (p=0.0055) (21/42 vs 35/130) • No association between meniscus surgery and need for FNB 5

Discussion

• Overall institutional change saved 67.5% of ACL-R patients from receiving a scheduled pre-operative FNB

• Gender, age, graft all associated with pain requiring FNB, greater sample size likely needed to determine other surgical variables

• Paradoxical finding of allografts more likely to need a block than autografts requires further investigation, may be due to confounding from gender and age

2 Thank you