The Journal of hand surgery · 2023
A Multicenter Prospective Randomized Comparison of Conduits Versus Decellularized Nerve Allograft for Digital Nerve Repairs.
Рандомизированное исследованиеМногоцентровое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Isaacs Jonathan, Nydick Jason A, Means Kenneth R, Merrell Gregory A, Ilyas Asif, Levin L Scott, RECON Study Group
Аннотация
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 18-69 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 (5-14 mm) and long (15-25 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.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.
METHODS: Patients (aged 18-69 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 (5-14 mm) and long (15-25 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.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.