Subtalar Arthrodesis with Use of Adipose-Derived Cellular Bone Matrix Compared with Autologous Bone Graft: A Multicenter, Randomized Controlled Trial
Abstract
BACKGROUND
Subtalar arthrodesis effectively treats subtalar joint arthritis when other interventions have failed. Nonunion is a known complication of subtalar arthrodesis, with reported rates ranging from 5% to 45%. Historically, open arthrodesis has been performed with use of autologous bone graft; however, there are inherent disadvantages to autologous bone graft, including donor-site morbidity. Mesenchymal stem cells, when placed on a cellular scaffold, have shown promise as an alternative to autologous bone graft. The purpose of this multicenter, randomized controlled trial was to assess the safety and efficacy of an adipose-derived cellular bone matrix (ACBM) composite made with live cells compared with autograft in subtalar arthrodesis.
METHODS
A total of 140 patients were enrolled in a prospective, randomized (1:1) controlled trial performed at 6 clinical sites in the U.S. End points, including radiographic, clinical, and functional outcomes, were assessed over 2 years of follow-up.
RESULTS
A total of 109 patients underwent arthrodesis with ACBM (52 patients) and autograft (57 patients). At 6 months, fusion was achieved in 16 patients (30.8%) in the ACBM group and 31 patients (54.4%) in the autograft group as measured on computed tomography (p = 0.024), and in 41 patients (78.8%) in the ACBM group and 50 patients (87.7%) in the autograft group as assessed on clinical and radiographic evaluation (p = 0.213). Quality-of-life outcome measures demonstrated significant…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 140 participants or records.
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