Diagnosis and Treatment of Adult Isthmic Spondylolisthesis | NASS Clinical Guidelines 1 G Evidence-Based Clinical Guidelines for Multidisciplinary Ethodolo
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Y Diagnosis and Treatment of Adult Isthmic Spondylolisthesis | NASS Clinical Guidelines 1 G Evidence-Based Clinical Guidelines for Multidisciplinary ETHODOLO Spine Care M NE I DEL I U /G ON Diagnosis and Treatment of I NTRODUCT Adult Isthmic I Spondylolisthesis NASS Evidence-Based Clinical Guidelines Committee D. Scott Kreiner, MD Jamie Baisden, MD Daniel Mazanec, MD Rakesh Patel, MD Robert Shay Bess, MD Committee Co- Diagnosis/Imaging Medical/Interventional Surgical Treatment Value Section Chair Chair and Natural Section Chair Treatment Section Section Chair History Section Chair Chair Douglas Burton, MD Amgad S. Hanna, MD Anil K. Sharma, MD Norman B. Chutkan, MD Steven W. Hwang, MD Christopher K. Taleghani, MD Bernard A. Cohen, PhD Cumhur Kilincer, MD, PhD Terry R. Trammel, MD Charles H. Crawford III, MD Mark E. Myers, MD Andrew N. Vo, MD Gary Ghiselli, MD Paul Park, MD Keith D. Williams, MD North American Spine Society Clinical Guidelines for Multidisciplinary Spine Care Diagnosis and Treatment of Adult Isthmic Spondylolisthesis Copyright © 2014 North American Spine Society 7075 Veterans Boulevard Burr Ridge, IL 60527 USA 630.230.3600 www.spine.org ISBNThis clinical 1-929988-37-0 guideline should not be construed as including all proper methods of care or excluding or other acceptable methods of care reason- ably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physi- cian and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. I NTRODUCT 2 Diagnosis and Treatment of Adult Isthmic Spondylolisthesis | NASS Clinical Guidelines Financial Statement This clinical guideline was developed and funded in its entirety by the North American Spine Society (NASS). All participating I authors have disclosed potential conflicts of interest consistent with NASS’ disclosure policy. Disclosures are listed below: ON /G U Scott Kreiner Nothing to disclose. (2/4/13) I DEL Jamie Baisden Nothing to disclose. (1/29/13) Range Key: I NE Robert Shay Bess Royalties: Pioneer (Level B); Consulting: Allosource, DePuy Spine (Level Level A. $100 to $1,000 M B), Alphatec (Level B), Medtronic (Level B); Speaking and/or teaching Level B. $1,001 to $10,000 arrangements: DePuy Spine (Level B), Medtronic (Level B); Trips/Travel: ETHODOLO DePuy Spine (Level B), Medtronic (Level B), Alphatec (Level B); Scientific Level C. $10,001 to $25,000 Advisory Board: Allosource (Level B); Research Support (Investigator Level D. $25,001 to $50,000 Salary): DePuy Spine (Level B), Medtronic (Level B); Grants: Orthopedic Level E. $50,001 to $100,000 Research and Education Foundation (Level C). (1/28/13) Level F. $100,001 to $500,000 G Norman B. Chutkan Royalties: Globus Medical (Level E); Speaking and/or teaching arrange- Level G. $500,001 to $1M Y ments: AO North America (Nonfinancial, Travel expenses and per diem); Level H. $1,000,001 to $2.5M Board of Directors: Walton Rehabilitation Hospital (Nonfinancial); Scien- Level I. Greater than $2.5M tific Advisory Board: Orthopedics Journal (Nonfinancial). (1/29/13) Bernard A. Cohen Stock Ownership: NuVasive (7000, 0, Shares equal less than 1/10th of 1% of outstanding shares), Medtronic (5000, 0, Shares equal less than 1/10th of 1% of outstanding shares), General Electric (10000, 0, Shares equal less than 1/10th of 1% of outstanding shares), Synthes (1000, 0, Shares equal less than 1/10th of 1% of outstanding shares), Zimmer (520, 0, Shares equal less than 1/10th of 1% of outstanding shares), Johnson & Johnson (1500, 0, Shares equal less than 1/10th of 1% of outstanding shares), Hanson Medical (1000, 0, Shares equal less than 1/10th of 1% of outstanding shares); Consulting: NuVasive (Less than Level B last calendar year), Johnson & Johnson (Less than Level B last calendar year); Speaking and/or teaching arrangements: Milwaukee School of Engineering (Nonfinancial, Bioengineering & Nursing Faculty Lectures), Numerous National and International Hospitals (Nonfinancial, Lecture and Teach Intraoperative Neurophysiology); Board of Directors: American Society for Neurophysiological Monitoring (Nonfinancial); Research Support (Staff/Materials): Neurovi- sion Medical Products (Level B, Supplied ET tubes). (1/29/13) Charles H. Crawford Consulting: Medtronic (D), Alphatec (D); Speaking and/or Teaching Arrangements: Depuy-Synthes (B); Trips/Travel: NASS (A), SRS (A); Other Office: Scoliosis Research Society (Nonfinancial, Committee Member), NASS (Nonfinan- cial, Committee Member) (11/01/13) Daniel P. Elskens Nothing to disclose. (2/7/13) Gary Ghiselli Private Investments: DiFusion (100000, 9); Consulting: Biomet (Level B for product development and teaching). (2/1/13) Amgad S. Hanna Nothing to disclose. (2/15/13) Steven W. Hwang Nothing to disclose. (1/29/13) Cumhur Kilincer Nothing to disclose. (1/29/13) Daniel J. Mazanec Consulting: First consult (Level A). (1/29/13) Mark E. Myers Stock Ownership: Spineology (2500, 1); Consulting: Spinewave (Level A/hour consulting). (2/7/13) Paul Park Consulting: Globus Medical (Level B), Medtronic (Level B); Speaking and/or teaching arrangements: Globus Medi- cal (Level C); Scientific Advisory Board: Neuralstem (Level B); Grants: NIH (Level B, Paid directly to institution/ employer), SMISS (Level B, Paid directly to institution/employer); Relationships Outside the One Year Requirement: DePuy (NASS Annual Meeting, 08/2011, Speaking and/or Teaching Arrangement, Level B). (1/27/13) Rakesh D. Patel Speaking and/or Teaching Arrangements: Stryker (Level B) and Globus (Level B) (11/7/13) Anil K. Sharma Nothing to disclose. (2/7/13) Christopher K. Taleghani Royalties: Seaspine (Level D), Globus (Less than Level A); Consulting: Seaspine (Level B), Theken (Level C); Speaking and/or teaching arrangements: Globus (Level B for teaching a course). (2/14/13) Terry R. Trammel Consulting: Medtronic (Level D in 2011, Level C in 2012), Biomet (Level C in 2011, Level C in 2012); Speaking and/ or teaching arrangements: Biomet (Financial, Amount is included in Consulting Income (1099) statement previously listed); Other: K2m (Financial, Participation in clinical data collection-paid for entering patient data per IRB autho- rization of enrolled patients. Also during 2011 compensated for my time and attendance at investigators meetings and presentations - estimated amount paid in 2011 Level B, 2012 Level C). (2/5/13) Andrew N. Vo Nothing to disclose. (2/8/13) Keith D. Williams Nothing to disclose. (2/3/13) Comments Comments regarding the guideline may be submitted to the North American Spine Society and will be considered in develop- ment of future revisions of the work. This clinical guideline should not be construed as including all proper methods of care or excluding or other acceptable methods of care reason- ably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physi- cian and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. Y Diagnosis and Treatment of Adult Isthmic Spondylolisthesis | NASS Clinical Guidelines 3 G Table of Contents ETHODOLO M NE I. Introduction ...................................................................4 I DEL I II. Guideline Development Methodology ..............................................5 U /G ON III. Summary of Recommendations....................................................8 I IV. Definition and Indicence ofAdult Isthmic Spondylolisthesis ............................13 NTRODUCT I V. Recommendations for Diagnosis and Treatment of Adult Isthmic Spondylolisthesis..........15 A. Natural History ................................................................15 B. Diagnosis/Imaging . 22 C. Outcome Measures for Medical/Interventional and Surgical Treatment . 34 D. Medical/Interventional Treatment . 35 E. Surgical Treatment ..............................................................41 F. Value of Spine Care .............................................................67 VI. Appendices...................................................................69 A. Acronyms.....................................................................69 B. Levels of Evidence for Primary Research Questions . .70 C. Grades of Recommendations for Summaries or Reviews of Studies.......................71 D. Linking Levels of Evidence to Grades of Recommendation ..............................72 E. NASS Literature Search Protocol ..................................................73 VII. References . 74 A technical report, including the literature search parameters and evidentiary tables developed by the authors, can be accessed at https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/ AdultIsthmicSpondyGuidelineTechReport.pdf. This clinical guideline should not be construed as including all proper methods of care or excluding or other acceptable methods of care reason- ably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physi- cian and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. I NTRODUCT 4 Diagnosis and Treatment of Adult Isthmic Spondylolisthesis | NASS Clinical Guidelines I ON I. Introduction /G Objective THIS GUIDELINE DOES NOT REPRESENT A “STAN- U DARD OF CARE,” I The objective of the North American Spine