Subtalar Arthrodesis with Use of Adipose-Derived Cellular Bone Matrix Compared with Autologous Bone Graft

Abstract

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 Dec 18;101(24):e139. 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.

In Vitro Cultures of Adipose-Derived Stem Cells: An Overview of Methods, Molecular Analyses, and Clinical Applications

“…Adipose-derived stem cells have also been used in the process of allograft preparation. The clinical utility of ASC allografts was tested in patients with subtalar joint arthritis as an alternative treatment to typical autologous bone graft in performed subtalar arthrodesis and both methods had similar efficacy in patients' quality of life enhancement [121,125]. Furthermore, it has been reported that the intradiscal injection of a mixture of ASCs and hyaluronic acid was safe for patients and could significantly reduce chronic discogenic low back pain [126].…”

“…Subtalar arthrodesis with use of adipose-derived cellular bone matrix compared with autologous bone graft: A multicenter, randomized controlled trial [125] Prospective, randomized, controlled trial…”

Measures of Foot Pain, Foot Function, and General Foot Health

“…The FFI‐R was developed with patients who were predominantly middle‐aged (mean of 69 years) men with foot arthritis . The questionnaire has also been used as an outcome measure for surgical studies .…”

“…The FFI‐R has been used as an outcome measure in clinical trials of medial knee osteoarthritis , first metatarsophalangeal joint osteoarthritis , plantar fasciitis , and diabetic foot ulcers and has been used to evaluate surgical implants .…”

Outcomes of Nitinol Compression Staples in Tarsometatarsal Fusion

“…[1][2][3]5,9,14 Numerous studies have demonstrated the safety and efficacy of the use of nitinol compression staples in TMT fusion 3,9,13,14,16,23 and generally have fusion rates near 90%, comparable to literature rated for conventional fixation. 19 Although some clinical data exist regarding union rate using BME ELITE compression staples in TMT fusion, the data lack objective preoperative and postoperative data and analysis. In this report, validated clinical outcome scores were used to assess the subjective efficacy of midfoot arthrodesis using the new generation of nitinol staples.…”