Daniels Timothy R, Younger Alastair S E, Penner Murray J, Wing Kevin J, Le Ian L D, Russell Iain S, Lalonde Karl-André, Evangelista Peter T, Quiton Jovelyn D, Glazebrook Mark, DiGiovanni Christopher W
Division of Orthopaedic Surgery, St Michael's Hospital and University of Toronto, Toronto, ON, Canada
Division of Distal Extremities, Department of Orthopaedics, University of British Columbia, Vancouver, BC, Canada BC's Foot and Ankle Clinic, St Paul's Hospital, Vancouver, BC, Canada.
Foot Ankle Int. 2015 Jul;36(7):739-48. doi: 10.1177/1071100715576370. Epub 2015 Apr 6.
Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (β-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions.
Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/β-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/β-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated.
Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/β-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P < .001). Mean time to fusion was 14.3 ± 8.9 weeks for rhPDGF-BB/β-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/β-TCP-collagen patients and 120 of 154 (78%) autograft patients (P < .001). Safety-related outcomes were equivalent. Autograft controls had 2 bone graft harvest infections.
Application of rhPDGF-BB/β-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting.
Level I, prospective randomized study.
踝关节和后足关节融合术常需补充自体骨移植以促进骨愈合。自体骨采集会导致围手术期发病率增加。纯化的重组人血小板衍生生长因子BB同二聚体（rhPDGF - BB）已刺激下颌骨缺损和后足融合中的骨形成。本随机对照试验评估了rhPDGF - BB联合可注射的骨传导性β - 磷酸三钙（β - TCP） - 胶原基质与自体骨移植在踝关节和后足融合中的疗效和安全性。
75例需要进行踝关节或后足融合的患者按5:1随机分为rhPDGF - BB/β - TCP - 胶原组（治疗组，n = 63）或自体骨移植组（对照组，n = 12）。前瞻性分析纳入了来自另一项具有相同研究方案的临床试验的142例自体骨移植对照受试者。采用标准化的手术和术后方案。患者接受自体骨移植或0.3 mg/mL rhPDGF - BB/β - TCP - 胶原增强的标准内固定。在52周内评估放射学、临床和生活质量结果。主要结局是24周时的关节融合（计算机断层扫描显示骨桥接达50%或更多）。次要结局包括X线片、临床愈合状态、视觉模拟评分疼痛评分、美国矫形足踝协会踝关节 - 后足评分、足部功能指数评分和简明健康调查12项评分。计算非劣效性P值。
计算机断层扫描显示，63例接受rhPDGF - BB/β - TCP - 胶原治疗的患者中有53例（84%）在24周时所有受累关节完全融合，154例接受自体骨移植治疗的患者中有100例（65%）完全融合（P <.001）。rhPDGF - BB/β - TCP - 胶原组患者的平均融合时间为14.3±8.9周，自体骨移植组患者为19.7±11.5周（P <.01）。63例rhPDGF - BB/β - TCP - 胶原组患者中有57例（91%）在52周时临床成功，154例自体骨移植组患者中有120例（78%）临床成功（P <.001）。与安全性相关的结果相当。自体骨移植对照组有2例骨移植采集部位感染。
rhPDGF - BB/β - TCP - 胶原的应用是踝关节和后足融合中自体骨移植的一种安全、有效的替代方法，消除了与自体骨采集相关的疼痛和发病率。
I级，前瞻性随机研究。
