Jones Carroll P, Loveland Jeffrey, Atkinson Brent L, Ryaby James T, Linovitz Raymond J, Nunley James A
OrthoCarolina Foot and Ankle Institute, Charlotte, NC, USA
Central Tennessee Foot and Ankle Center, Sparta, TN, USA.
Foot Ankle Int. 2015 Oct;36(10):1129-37. doi: 10.1177/1071100715586181. Epub 2015 May 14.
Cellular bone allograft (CBA) possesses osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study was to assess the safety and effectiveness of CBA in foot and/or ankle arthrodeses.
A prospective, multicenter, open-label clinical trial using CBA was performed. At 6 weeks and at 3, 6, and 12 months, imaging was performed and the subject's pain, function, and quality of life (QOL) status (Visual Analog Scale, American Orthopaedic Foot & Ankle Society Hindfoot Scale, and the Short Form 36) were recorded. The per protocol population consisted of 92 patients at 6 months and 76 patients at 12 months, with 153 and 129 total arthrodeses, respectively.
At 6 months, fusion rates were 68.5% for all patients and 81.1% for all joints; at 12 months, rates were 71.1% and 86.8%, respectively. Certain high-risk subjects (eg, with diabetes or obesity) had fusion rates comparable to those of normal patients. Statistically significant improvements in pain, function, and QOL were observed, and fusion correlated with both function and QOL outcomes at 6 and 12 months. There were no adverse events attributable to CBA.
Fusion rates using CBA were higher than or comparable to fusion rates with autograft that have been reported in the recent literature, and CBA fusion rates were not adversely affected by several high-risk patient factors. CBA was a safe and effective graft material to achieve fusion in patients with compromised bone healing and may provide an effective autograft replacement for foot and/or ankle arthrodeses.
Level II, prospective study.
细胞骨移植（CBA）具有骨愈合所必需的成骨、骨诱导和骨传导成分。本研究的目的是评估CBA在足和/或踝关节融合术中的安全性和有效性。
进行了一项使用CBA的前瞻性、多中心、开放标签临床试验。在6周以及3、6和12个月时进行影像学检查，并记录受试者的疼痛、功能和生活质量（QOL）状况（视觉模拟量表、美国矫形足踝协会后足量表和简短健康调查问卷36项）。符合方案人群在6个月时包括92例患者，12个月时包括76例患者，分别有153例和129例全关节融合术。
在6个月时，所有患者的融合率为68.5%，所有关节的融合率为81.1%；在12个月时分别为71.1%和86.8%。某些高危受试者（如患有糖尿病或肥胖症）的融合率与正常患者相当。观察到疼痛、功能和QOL有统计学意义的改善，并且在6个月和12个月时融合与功能和QOL结果相关。没有可归因于CBA 的不良事件。
使用CBA的融合率高于或与近期文献报道的自体移植融合率相当，并且CBA融合率不受几个高危患者因素的不利影响。CBA是一种安全有效的移植材料，可用于骨愈合受损患者实现融合，并且可能为足和/或踝关节融合术提供有效的自体移植替代物。
二级，前瞻性研究。
