A Multicenter Prospective Randomized Comparison of Conduits Versus Decellularized Nerve Allograft for Digital Nerve Repairs

Purpose While there are advantages and disadvantages to both processed nerve allografts (PNA) and conduits, a large, well-controlled prospective study is needed to compare the efficacy and to delineate how each of these repair tools can be best applied to digital nerve injuries. We hypothesized that PNA digital nerve repairs would achieve superior functional recovery for longer length gaps compared with conduit-based repairs. Methods Patients (aged 18e69 years) presenting with suspected acute or subacute (less than 24 weeks old) digital nerve injuries were recruited to prticipate at 20 medical centers across the United States. After stratification to short (5e14 mm) and long (15e25 mm) gap subgroups, the patients were randomized (1:1) to repair with either a commercially available PNA or collagen conduit. Baseline and outcomes assessments were obtained either before or immediately after surgery and planned at 3-, 6-, 9-, and 12-months after surgery. All assessors and patients were blinded to the treatment arm. Results In total, 220 patients were enrolled, and 183 patients completed an acceptable last evaluable visit (at least 6 months and not more than 15 months postrepair). At last follow-up, for the short gap repair groups, average static two-point discrimination was 7.3 +/- 2.8 mm for PNA and 7.5 +/- 3.1 mm for conduit repairs. For the long gap group, average static two-point discrimination was significantly lower at 6.1 +/- 3.3 mm for PNA compared with 7.5 +/- 2.4 mm for conduit repairs. Normal sensation (American Society for Surgery of the Hand scale) was achieved in 40% of PNA long gap repairs, which was significantly more than the 18% observed in long conduit patients. Long gap conduits had more clinical failures (lack of protective sensation) than short gap conduits. Conclusions Although supporting similar levels of nerve regeneration for short gap length digital nerve repairs, PNA was clinically superior to conduits for long gap reconstructions. (J Hand Surg Am. 2023;48(9):904-913. Copyright (c) 2023 by the American Society for Surgery of the Hand. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).)