Dalhousie University, Halifax, NS, Canada.
Foot Ankle Int. 2013 Aug;34(8):1055-63. doi: 10.1177/1071100713481459. Epub 2013 Mar 5.
To reduce fusion nonunion, autogenous bone graft is often incorporated into foot and ankle fusion procedures. B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 μg B2A/cm(3) ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis. The purpose of this study was to perform a multicenter prospective randomized pilot clinical trial designed to compare the safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery.
This study was a multicenter, prospective, randomized, pilot clinical trial designed to compare safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. Twenty-four patients were enrolled and randomized (1:1) into 2 groups: autogenous bone graft control and B2A-granule. Primary outcome measures at 6 months (with follow-up at 9 and 12 months) included radiographic fusion assessed by computerized tomography and Ankle Osteoarthritis Scale scores for pain and disability.
Radiographic fusion success rates were similar in both groups (100% in the B2A-granule group, 92% autograft). Both the B2A-granule group and the autograft group had improvements in the pain and disability scores over the course of the study. Graft harvest-site pain affected only autograft-treated patients. There were no adverse events attributed to the graft material in either the B2A-granule or autograft group.
The results of this pilot study are supportive of a larger clinical trial to assess the safety and efficacy of B2A-granule as a bone graft substitute in foot and ankle fusions.
Level II, prospective comparative study.
为了降低融合不愈合，自体骨移植物常被用于足踝关节融合术。B2A 肽涂层陶瓷颗粒在经椎间孔腰椎体间融合的初步研究中取得了令人鼓舞的结果，在这里被重新配方制成 Amplex，其陶瓷颗粒（B2A 颗粒）的涂层浓度为 225μgB2A/cm3，目的是在足踝关节融合术中消除自体骨移植物。本研究旨在进行一项多中心前瞻性随机试点临床试验，比较 B2A 颗粒与自体骨移植物在接受足踝关节融合术患者中的安全性和有效性。
这是一项多中心、前瞻性、随机、试点临床试验，旨在比较 B2A 颗粒与自体骨移植物在接受足踝关节融合术患者中的安全性和有效性。24 名患者被纳入并随机（1:1）分为两组：自体骨移植物对照组和 B2A 颗粒组。主要结局指标在 6 个月（随访 9 个月和 12 个月）时包括计算机断层扫描评估的影像学融合和踝关节骨关节炎量表的疼痛和残疾评分。
两组的影像学融合成功率相似（B2A 颗粒组 100%，自体骨移植物组 92%）。B2A 颗粒组和自体骨移植物组在研究过程中疼痛和残疾评分均有所改善。仅自体骨移植物组患者出现供骨部位疼痛。B2A 颗粒组和自体骨移植物组均未发生与移植物材料相关的不良事件。
该试点研究结果支持进行更大规模的临床试验，以评估 B2A 颗粒作为足踝关节融合的骨移植替代物的安全性和有效性。
II 级，前瞻性比较研究。
