UPDATE: This article was updated on November 7, 2019, because of a previous error. On page 1909, in the section entitled "Discussion," the sentence that had read "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs" now reads "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do not account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs."An erratum has been published: J Bone Joint Surg Am. 2019 XXX. 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 anadipose-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 functional improvement from baseline for both groups. Fewer cases of serious adverse events occurred in the autograft group (10.5%) compared with the ACBM group (23.1%) (p = 0.078). CONCLUSIONS: In patients who require subtalar arthrodesis, the use of ACBM demonstrated lower rates of radiographic fusion compared with treatment with autograft. The nonunion rate in the autologous group, as measured on computed tomography, was high. Good clinical outcomes were achieved in spite of the high non-union rates. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
UPDATE: This article was updated on November 7, 2019, because of a previous error. On page 1909, in the section entitled "Discussion," the sentence that had read "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs" now reads "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do not account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs."An erratum has been published: J Bone Joint Surg Am. 2019 XXX. 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 functional improvement from baseline for both groups. Fewer cases of serious adverse events occurred in the autograft group (10.5%) compared with the ACBM group (23.1%) (p = 0.078). CONCLUSIONS: In patients who require subtalar arthrodesis, the use of ACBM demonstrated lower rates of radiographic fusion compared with treatment with autograft. The nonunion rate in the autologous group, as measured on computed tomography, was high. Good clinical outcomes were achieved in spite of the high non-union rates. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.