Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a -TCP-Collagen Matrix
Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a -TCP-Collagen Matrix
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DOI：
10.1177/1071100715576370
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发表时间：
2015-07-01
影响因子：
2.7
通讯作者：
DiGiovanni, Christopher W.
中科院分区：
文献类型：
--
作者：
Daniels, Timothy R.;Younger, Alastair S. E.;DiGiovanni, Christopher W.
背景：踝关节和后足关节固定术通常辅以自体移植物以促进骨愈合。自体移植物收获可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同源二聚体（rhPDGF-BB）刺激下颌骨缺损和后足融合的骨形成。本随机对照试验评价了rhPDGF-BB与可注射的骨传导性β-磷酸三钙（-TCP）-胶原基质联合应用与自体移植物在踝关节和后足fusions.Methods：75例需要踝关节或后足融合术的患者按5：1的比例随机分为rhPDGF-BB/-TCP-胶原（治疗组，n = 63）或自体移植物（对照组，n = 12）。前瞻性分析包括来自另一项临床试验的142例自体移植物对照受试者，研究方案相同。采用标准化的手术和术后方案。患者接受标准内固定，并使用自体移植物或0.3 mg/mL rhPDGF-BB/-TCP-胶原增强。在52周内评估放射学、临床和生活质量结局。主要结局为24周时的关节融合（计算机断层扫描显示50%或更多骨桥接）。次要结局包括X线片、临床愈合状态、视觉模拟量表疼痛评分、美国足踝矫形协会踝关节-后足量表评分、足功能指数评分和简表-12评分。结果：计算机断层扫描显示，63例rhPDGF-BB/-TCP-胶原治疗患者中有53例（84%）和154例自体移植治疗患者中有100例（65%）在24周时实现了所有受累关节的完全融合（P <0.001）。rhPDGF-BB/-TCP-胶原患者的平均融合时间为14.3 ± 8.9周，而自体移植患者为19.7 ± 11.5周（P <0.01）。在52周时，63名rhPDGF-BB/-TCP-胶原患者中的57名（91%）和154名自体移植患者中的120名（78%）获得了临床成功（P < .001）。安全性相关结局等同。自体移植物对照组有2个骨移植收获infections.Conclusions：应用rhPDGF-BB/-TCP-胶原是一种安全、有效的替代自体移植物用于踝关节和后足融合，消除了与自体移植物收获相关的疼痛和发病率。证据等级：I级，前瞻性随机研究。
Background: 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 (-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions.Methods: Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/-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/-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.Results: Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/-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/-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/-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.Conclusions: Application of rhPDGF-BB/-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting.Level of Evidence: Level I, prospective randomized study.