University Orthopaedics, Inc., 100 Butler Dr., Providence, RI 02906, USA.
Foot Ankle Int. 2011 Apr;32(4):344-54. doi: 10.3113/FAI.2011.0344.
The increased morbidity and surgical time associated with harvesting autologous bone graft (ABG) have encouraged surgeons to develop synthetic orthobiologic alternatives. The recombinant form of platelet-derived growth factor (rhPDGF-BB), an angiogenic, mitogenic, and chemotactic cytokine, has been shown to significantly enhance bone formation in human periodontal osseous defects when combined with a tricalcium phosphate carrier (β-TCP). The purpose of this prospective, controlled, randomized, multi-center feasibility clinical trial was to compare the safety and efficacy of this biosynthetic bone graft substitute (Augment™ Bone Graft) to ABG during ankle and hindfoot fusion.
Twenty adult subjects requiring ankle or hindfoot fusion from three U.S. centers were enrolled and randomized in a 2:1 ratio to receive Augment™ or ABG, respectively. Surgical approach and fixation techniques were standardized, and minimum followup was 9 months. The primary endpoint was radiographic osseous union, evaluated by a blinded independent radiologist. Secondary endpoints included assessment of clinical success, union rate by serial computed tomography (CT) examination, time to full weightbearing, AOFAS Ankle-Hindfoot Score (AOFAS), Foot Function Index (FFI), Short Form-12 (SF-12), and Visual Analog pain assessment Scale (Pain VAS).
At 36 weeks, 77% (10/13) of the Augment™ and 50% (3/6) of the ABG patients were fused based on radiographic criteria. There were two nonunions in the Augment™ group (9%, 2/14). Healing rates based on 12 week CT scanning (50% osseous bridging) were 69% (9/13) in the Augment™ and 60% (3/5) in the ABG groups, respectively. All functional outcome measures (FFI, AOFAS, SF-12), as well as the VAS pain scores, improved in both groups over time. Surgical procedure times lasted an average 26 minutes longer for the ABG as compared to the Augment™ populations. There were no device related serious adverse events in this study.
Based on the available data, the rate of radiographic union, time to full weightbearing, and outcomes scores between the Augment™ and ABG subjects appear comparable. Augment™ may represent a safe and efficacious treatment alternative to ABG during foot and ankle arthrodesis.
自体骨移植物（ABG）相关发病率和手术时间的增加促使外科医生开发合成的骨生物替代品。血小板衍生生长因子（rhPDGF-BB）的重组形式是一种血管生成、有丝分裂和趋化细胞因子，当与三钙磷酸盐载体（β-TCP）结合使用时，已被证明可显著增强人牙周骨缺损中的骨形成。本前瞻性、对照、随机、多中心可行性临床试验的目的是比较在踝关节和后足融合中使用这种生物合成骨移植物替代物（Augment 骨移植物）与 ABG 的安全性和有效性。
从三个美国中心招募了 20 名需要踝关节或后足融合的成年受试者，并按照 2:1 的比例随机分配接受 Augment 或 ABG。标准化了手术入路和固定技术，最低随访时间为 9 个月。主要终点是由盲法独立放射科医生评估的放射学骨融合。次要终点包括临床成功率评估、连续 CT 检查的融合率、完全负重时间、AOFAS 踝关节-后足评分（AOFAS）、足功能指数（FFI）、简短形式 12 项（SF-12）和视觉模拟疼痛评估量表（疼痛 VAS）。
在 36 周时，根据放射学标准，13 例中的 77%（10/13）接受 Augment 治疗的患者和 6 例中的 50%（3/6）接受 ABG 治疗的患者融合。Augment 组有 2 例非融合（9%，2/14）。根据 12 周 CT 扫描（50%骨桥接），Augment 组的愈合率为 69%（9/13），ABG 组为 60%（3/5）。随着时间的推移，所有功能评估量表（FFI、AOFAS、SF-12）以及疼痛 VAS 评分均在两组中得到改善。与接受 Augment 的患者相比，ABG 患者的手术时间平均延长 26 分钟。本研究中无与器械相关的严重不良事件。
根据现有数据，Augment 和 ABG 受试者的放射学融合率、完全负重时间和结果评分似乎相当。在足踝关节融合术中，Augment 可能是 ABG 的一种安全有效的替代治疗方法。
