Outcomes from the Addition of an Autograft and Tube Conduit Contemporary Control Cohort for RANGERŽ: A Registry Study of Processed Nerve Allograft Repair Outcomes
Bauback Safa, MD1; Brian D. Rinker, MD2; Gregory M. Buncke, MD1
1The Buncke Clinic, San Francisco, CA; 2Division of Plastic Surgery, University of Kentucky, Lexington, KY
Introduction: The RANGER registry is an active database designed to continuously monitor and collect injury, repair, safety and outcomes data for processed nerve allografts (AvanceŽ Nerve Graft, AxoGen, Inc). In 2013, contemporary control groups (MATCH) were added to the registry to allow for comparisons of outcomes between nerve autograft and tube conduit. Here we report our early findings from these control groups as compared to the active database and historical literature.
Methods: Initial screening of medical records was conducted at participating centers to identify potential subjects presenting with nerve gap injuries repaired with either nerve autograft or nerve tube conduit. Identified records meeting inclusion/exclusion criteria with sufficient follow-up were assigned a unique identifier according to the IRB approved protocol. The contemporary control was analyzed and comparisons were made between treatment groups by site. Response to treatment was defined as reported improvement from baseline. Meaningful recovery was defined by the MRCC scale at S3/M3 or greater for sensory and motor function.
Results: This cumulative dataset included 41 subjects with 55 nerve injuries in the upper extremity distal to the elbow reconstructed with processed nerve allograft (n=34), tube conduit (n=13), or nerve autograft (n=8). Subject demographics, medical history, and concomitant injuries were comparable between treatment groups. The average nerve gap between the groups varied at 24±12mm, 11±4 mm, and 57±30mm for processed nerve allograft, conduit, and nerve autograft respectively. Available quantitative data reported meaningful levels of recovery in 80% of nerve allografts as compared to 43% of tube conduits. There were no reported adverse events related to the treatment groups. See Table 1 for a summary of treatment groups and comparisons to reference literature.
Conclusion: Reported levels of meaningful recovery for processed nerve allografts exceed that of tube conduits. These results were also consistent with outcomes reported in the literature. The MATCH control arm of the RANGER registry remains ongoing; additional clinical data collected from participating sites will allow for further understanding and comparison of these three treatment modalities.
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