TY - JOUR
T1 - A Multicenter Prospective Randomized Comparison of Conduits Versus Decellularized Nerve Allograft for Digital Nerve Repairs
AU - Isaacs, Jonathan
AU - Nydick, Jason A.
AU - Means, Kenneth R.
AU - Merrell, Gregory A.
AU - Ilyas, Asif
AU - Levin, L. Scott
AU - Bozentka, David
AU - Steinberg, David
AU - Gray, Benjamin
AU - Lin, Ines
AU - Frankenhoff, Jessica
AU - Cotterell, Ilvy
AU - Rinker, Brian
AU - Duggal, Anil
AU - Bourne, Debra
AU - Drake, David
AU - Wong, Lesley
AU - Stewart, Daniel
AU - Liau, James
AU - Vasconez, Henry
AU - Li, Zhongyu John
AU - Butler, Katherine
AU - Graves, Benjamin
AU - Koman, L. Andrew
AU - Wiesler, Ethan
AU - Papadonikolakis, Anastasios
AU - Nunez, Fiesky
AU - Bayne, Christopher
AU - Szabo, Robert
AU - Deal, D. Nicole
AU - Chhabra, A. Bobby
AU - Behar, Brittany
AU - Dacus, Angelo
AU - DeGeorge, Brent
AU - Freilich, Aaron
AU - Hammert, Warren
AU - Ketonis, Constantinos
AU - Higgins, James
AU - Katz, Ryan
AU - LaPorte, Dawn
AU - Paryavi, Ebrahim
AU - Wittstadt, Raymond
AU - Giladi, Avarim
AU - Sadhu, Anita
AU - Zimmerman, Neal
AU - Zimmerman, Ryan
AU - Spiess, Alexander
AU - Acarturk, Tahsin
AU - Solari, Mario
AU - Greenberg, Jeffrey
N1 - Publisher Copyright:
© 2023
PY - 2023/9
Y1 - 2023/9
N2 - 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.
AB - 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.
KW - Conduits
KW - digital nerves
KW - nerve graft
KW - nerve repair
KW - processed acellular nerve allograft
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U2 - 10.1016/j.jhsa.2023.05.020
DO - 10.1016/j.jhsa.2023.05.020
M3 - Article
C2 - 37530686
AN - SCOPUS:85170111258
SN - 0363-5023
VL - 48
SP - 904
EP - 913
JO - Journal of Hand Surgery
JF - Journal of Hand Surgery
IS - 9
ER -