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Effectiveness of Ultraporous Β-Tricalcium Phosphate (Vitoss) As Bone Graft Substitute for Cavitary Defects in Benign and Low-Grade Malignant Bone Tumors

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Effectiveness of Ultraporous Β-Tricalcium Phosphate (Vitoss) As Bone Graft Substitute for Cavitary Defects in Benign and Low-Grade Malignant Bone Tumors An Original Study Effectiveness of Ultraporous β-Tricalcium Phosphate (Vitoss) as Bone Graft Substitute for Cavitary Defects in Benign and Low-Grade Malignant Bone Tumors Corey Van Hoff, MD, Julie Balch Samora, MD, MPH, PhD, Michael J. Griesser, MD, Martha K. Crist, RN, BSH, Thomas J. Scharschmidt, MD, and Joel L. Mayerson, MD the graft to promote eventual bone growth into the cavity. Abstract Given their osteogenic, inductive, and conductive proper- We retrospectively evaluated healing with ultrapor- ties, autologous bone grafts have been the gold standard ous β-tricalcium phosphate (β-TCP [Vitoss; Orthovida, of management.3 However, harvesting these grafts can lead Malvern, Pennsylvania]) bone graft in patients who to higher morbidity, including infections, hematomas, neu- underwent surgical excision or curettage of benign bone rovascular injuries, wound healing problems, heterotopic lesions subsequently filled with bone void filler. Twenty- nine patients were treated with curettage and ultrapor- bone formation, cosmetic deformities, pain, and prolonged 4,5 ous β-TCP morsels. Radiologic defect size at initial anesthesia time. postoperative presentation and subsequent visits (mini- Cancellous or cortical bone allografts, which can be mum follow-up, 6 months) was evaluated. Results sug- fresh-frozen or freeze-dried, are a successful alternative to gested that an ultraporous β-TCP synthetic bone graft is autografts, as they have osteoconductive properties and effective in managing bone voids. The vast majority of provide comparable results.6,7 Banked allograft bone, how- patients who undergo curettage for benign bone lesions ever, is slow to incorporate, has the potential for immunoge- can expect to have complete or near complete healing of nicity, and has been known to carry bacteria and viruses.8-10 these defects within 6 months of their surgical procedure Tomford and colleagues8 reported allograft infection rates with use of ultraporous β-TCP morsels. as low as 1% based only on patients who had a positive culture from a preoperative allograft. However, they found urgical management of some benign and low-grade an allograft infection rate of 3.6% when patients with a malignant bone tumors involves lesion curettage and proven postoperative infection were included and a rate of leaving the resultant defect empty (when filler is con- 6.9% when all patients with postoperative infection were traindicated, as in the presence of acute or chronic included. In a study performed in the United Kingdom,11 Sinfection), or filling it with bone graft or synthetic bone void patients who received banked femoral heads over 1 year filler in an attempt to promote and accelerate healing.1,2 were compared with patients who underwent autograft Wishing to minimize healing time and restore intrinsic procedures. The banked allograft group had an infection bone strength, most surgeons prefer to graft the defect. rate of 12.2%, and the autograft group had a rate of 3.5%. The goal of this surgery is to completely fill the defect with Interestingly, the procedure failure rate was 50% when there was a postoperative infection but only 4.2% where there was Dr. Van Hoff is Assistant Professor, Dr. Samora and Dr. Griesser no infection. The authors concluded that procedures using are Resident Physicians, Ms. Crist is Nurse, and Dr. Scharschmidt banked allograft bone have a higher infection risk and a is Assistant Professor, Department of Orthopaedics, Ohio State higher failure rate. University Medical Center, Columbus, Ohio. Dr. Mayerson is Associate Professor, Ohio State University Synthetic bone grafts are safer for patients because of Medical Center, Columbus, Ohio; Director of Musculoskeletal no additional donor-site morbidity, no risk for disease Oncology, Arthur James Cancer Hospital, Ohio State University, transmission, less operating time, and unlimited availabil- Columbus, Ohio; and Program Director, Orthopaedics Residency ity. Calcium-based bone void fillers have long been used Program, and Co-Director, Bone Tumor Clinic, Nationwide as bone graft.12,13 They are osteoconductive and resorbed Children’s Hospital, Columbus, Ohio. at varying rates, depending on their specific chemical and Address correspondence to: Thomas J. Scharschmidt, MD, physical properties. Division of Musculoskeletal Oncology, 1st Floor, Arthur James Vitoss (Orthovida, Malvern, Pennsylvania) is a synthetic, Cancer Hospital, Ohio State University, 300 W 10th Ave, calcium-based bone graft expander made of ultraporous Columbus, OH 43210-1280 (tel, 614-293-4420; fax, 614-293- β-tricalcium phosphate (β-TCP), or Ca (PO ) . This most 3747; e-mail, [email protected]). 3 4 2 porous of β-TCP bone fillers received US Food and Drug 14 Am J Orthop. 2012;41(1):20-23. Copyright Quadrant HealthCom Administration clearance in December 2000. Ultraporous Inc. 2012. All rights reserved. β-TCP bone filler has properties of both macroporosity, 20 The American Journal of Orthopedics® www.amjorthopedics.com C. Van Hoff et al A B A B Figure 1. Representative preoperative (A) and 24-month postop- Figure 3. Representative preoperative (A) and 5-year postopera- erative (B) images of grade 2 filling defect of proximal humerus tive (B) images of grade 4 filling defect (A, arrow) after curet- after curettage and filling with ultraporous β-tricalcium phos- tage and filling of enchondroma with ultraporous β-tricalcium phate (Vitoss) morsels. phosphate morsels. Defect is indistinguishable from surrounding bone (B). Patients who underwent surgical excision or curettage of benign bone lesions that required a bone void filler were treated with ultraporous β-TCP morsels. Eighty-five patients who underwent surgery between January 1, 2003, and October 31, 2005, were evaluated. Preoperative and postoperative clinical and radiographic outcomes were assessed with outpatient medical records and orthopedic radiographs at 2 weeks to 6 weeks, 3 months, 6 months, and, if necessary, 12 months. Only those patients with a diagnosed bone tumor that required surgical manage- ment, including use of bone graft material, were included A B in the study (29 patients). Patients were excluded if they participated in another investigational drug or device trial, Figure 2. Representative preoperative (A) and 20-month post- operative (B) images after curettage and filling (with ultraporous participated in a study that would interfere with the param- β-tricalcium phosphate morsels) of tibial defect secondary to eters being studied under this protocol, lacked preoperative fibrous dysplasia. Defect is still apparent, but bony trabeculae imaging at our facility, were lost to follow-up, had no cor- traverse void. This is considered a grade 3 filling defect. responding pathology, and used medication for osteoporosis (56 patients). which allows for new bone appositional growth, and micro- After curettage, each lesion underwent grafting with porosity, which allows for fluid and nutrient transport. It is a ultraporous β-TCP morsels without use of bone marrow highly biocompatible osteoconductive bone graft expander aspirate. A special inserter was used to fill the defects. that facilitates trabecular bone formation. Packing was done manually, so as to fill the defects com- We conducted a study to evaluate healing as demon- pletely and without crushing the microporous superstruc- strated by radiographic resolution of benign bone tumors ture. The dry ultraporous β-TCP mixture was gently packed managed with ultraporous β-TCP and to determine whether into the defects and slightly overcompressed. Defect volume ultraporous β-TCP is effective in managing bone voids in was calculated according to the methods of Damron.14 patients who undergo curettage for benign bone lesions. All patients were followed clinically and radiographically for a mean (range) of 17.2 (6-34.5) months after surgery. MATERIALS AND METHODS Radiographs were obtained at each follow-up, and defect This study was a retrospective, uncontrolled review of 29 volume was calculated, thus permitting calculation of the consecutive patients with benign or low-grade malignant proportion of the lesion healed at each time point. Defects bone tumors. The senior author (J.L.M.) treated all patients were graded on a 4-point scale on the latest follow-up radio- with curettage and bone grafting using ultraporous β-TCP graph: grade 1 (lucency traversing entire defect space), grade as a bone void filler without use of bone marrow aspirate. 2 (lucency partly traversing entire defect space), grade 3 (tra- Additional hardware was used, depending on lesion size and beculae crossing entire defect space), and grade 4 (defect no location and presence or absence of pathologic fracture. All longer distinguishable from surrounding bone). patients were followed clinically and radiographically for a Summary statistics for age, sex, initial lesion size, and minimum of 6 months; some patients had a 5-year follow- length of follow-up were computed. To normalize the data up. We obtained institutional review board approval before across patients, we recorded an outcome measure of the starting this review. proportion of the initial lesion healed at each follow-up. www.amjorthopedics.com January 2012 21 Ultraporous β-Tricalcium Phosphate (Vitoss) as Bone Graft Substitute Table. Patient Demographics Age, y Sex Diagnosis Location Defect Size, mL 38 F Enchondroma Humerus 4.4×2.6×2.5 = 28.6 66 F Enchondroma Metatarsus 5.3×2.0×1.6 = 17.0 61 F Unknown, benign Femoral neck 4.0×3.7×2.3 = 34.0 48 F Enchondroma Humerus
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