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Cold Intolerance Following Digital Nerve Injury – A Multicenter Prospective Randomized Comparison of Decellularized Nerve Allograft versus Nerve Conduits.
Asif M Ilyas, MD
1; David Kirby, MD
2; Matthew Peterson, PhD
3; L Scott Levin, MD
4; Jonathan Isaacs, MD
51Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA; 2Rothman, Philadelphia, PA; 3AxoGen Inc, Alachua, FL; 4Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; 5Department of Orthopaedics, Virginia Commonwealth University, Richmond, VA
Hypothesis: Cold intolerance following digital nerve injury is a common complication with associated patient burden. To better understand how cold intolerance evolves in the setting of digital nerve injuries, a sub-analysis of a randomized controlled trial comparing conduit-based (CONDUIT) and processed nerve allograft (PNA) repairs was undertaken. It was hypothesized that PNA based repairs would have improved cold intolerance compared to CONDUIT repairs, particularly for longer length gaps.
Methods: A multicenter trial with 20 United States based medical centers was undertaken with patient inclusion being 18 to 69 year old patients presenting with a digital nerve injury less than 24 weeks old. Patients were randomized (1:1) to commercially available PNA or collagen CONDUIT repairs. Cold Intolerance Symptoms Severity (CISS) scores, as well as sensory function testing, were collected at baseline, 3-, 6-, 9-, and 12-months after surgery. All patients and assessors were blinded to treatment arm.
Results: In total, 220 patients were enrolled and randomized to CONDUIT vs PNA repair, with 183 patients included in final analysis with at least 6 months follow up. At last evaluable visit (LEV), the mean CISS score decreased from a baseline of 31.15 +/- 27.87 to 20.76 +/- 19.72 and 31.16 +/- 30.68 to 25.93 +/- 24.07 for PNA and CONDUIT, respectively. On sub-analysis, there were significantly more patients who converted from severe/extremely severe cold intolerance to mild cold intolerance for PNA relative to CONDUIT, both at one month and LEV (p<0.05). There was a significant correlation between CISS score and sensory function testing.
Summary: Although no correlation was demonstrated with nerve gap size, digital nerve gap repaired with PNA had significantly improved cold tolerance outcomes for patients with more severe cold intolerance at baseline relative to nerves repaired with CONDUIT.
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