Prospective, Multicenter Evaluation of Allogeneic Bone Matrix Containing Viable Osteogenic Cells in Foot and/or Ankle...

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.