Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 904-913 |
| Number of pages | 10 |
| Journal | Journal of Hand Surgery |
| Volume | 48 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 2023 |
Bibliographical note
Publisher Copyright:© 2023
Funding
The authors would like to thank AxoGen, Inc. for the complete support of this study. The members of the RECON Study Group are as follows (∗indicates center primary investigator): David Bozentka, MD (University of Pennsylvania, Penn Medicine, Philadelphia, PA),∗ L. Scott, Levin, MD (University of Pennsylvania, Penn Medicine, Philadelphia, PA), David Steinberg, MD (University of Pennsylvania, Penn Medicine, Philadelphia, PA), Benjamin Gray, MD (University of Pennsylvania, Penn Medicine, Philadelphia, PA), Ines Lin, MD (University of Pennsylvania, Penn Medicine, Philadelphia, PA), Jonathan Isaacs, MD (Virginia Commonwealth University Medical Center, Richmond, VA),∗ Jessica Frankenhoff, MD (Virginia Commonwealth University Medical Center, Richmond, VA), Ilvy Cotterell, MD (Virginia Commonwealth University Medical Center, Richmond, VA), Brian Rinker, MD, FACS (University of Kentucky Medical Center, Lexington, KY),∗ Anil Duggal, BSc, MD, MSc, FRCS (University of Kentucky Medical Center, Lexington, KY),∗ Debra Bourne, MD (University of Kentucky Medical Center, Lexington, KY),∗ David Drake, MD (University of Kentucky Medical Center, Lexington, KY), Lesley Wong, MD (University of Kentucky Medical Center, Lexington, KY), Daniel Stewart, MD (University of Kentucky Medical Center, Lexington, KY), James Liau, MD (University of Kentucky Medical Center, Lexington, KY), Henry Vasconez, MD (University of Kentucky Medical Center, Lexington, KY), Zhongyu John Li, MD, PhD (Wake Forest Medical Center, Winston-Salem, NC),∗ Katherine Butler, MD (Wake Forest Medical Center, Winston-Salem, NC), Benjamin Graves, MD (Wake Forest Medical Center, Winston-Salem, NC), L. Andrew Koman, MD (Wake Forest Medical Center, Winston-Salem, NC), Ethan Wiesler, MD (Wake Forest Medical Center, Winston-Salem, NC), Anastasios Papadonikolakis, MD (Wake Forest Medical Center, Winston-Salem, NC), Fiesky Nunez, Sr, MD (Wake Forest Medical Center, Winston-Salem, NC), Christopher Bayne, MD (University of California Davis Medical Center, Sacremento, CA),∗ Robert Szabo, MD (University of California Davis Medical Center, Sacremento, CA), D. Nicole Deal, MD (University of Virginia Medical Center, Charlottesville, VA),∗ A. Bobby Chhabra, MD (University of Virginia Medical Center, Charlottesville, VA),∗ Brittany Behar, MD (University of Virginia Medical Center, Charlottesville, VA), Angelo Dacus, MD (University of Virginia Medical Center, Charlottesville, VA), Brent DeGeorge, MD (University of Virginia Medical Center, Charlottesville, VA), Aaron Freilich, MD (University of Virginia Medical Center, Charlottesville, VA), Warren Hammert, DDS, MD (University of Rochester Medical Center, Rochester, NY),∗ Constantinos Ketonis, MD, PhD (University of Rochester Medical Center, Rochester, NY), Kenneth R. Means, MD (The Curtis National Hand Center, Baltimore, MD),∗ James Higgins, MD (The Curtis National Hand Center, Baltimore, MD), Ryan Katz, MD (The Curtis National Hand Center, Baltimore, MD), Dawn LaPorte, MD (The Curtis National Hand Center, Baltimore, MD), Ebrahim Paryavi, MD (The Curtis National Hand Center, Baltimore, MD), Raymond Wittstadt, MD (The Curtis National Hand Center, Baltimore, MD), Avarim Giladi, MD (The Curtis National Hand Center, Baltimore, MD), Anita Sadhu, MD (The Curtis National Hand Center, Baltimore, MD), Neal Zimmerman, MD (The Curtis National Hand Center, Baltimore, MD), Ryan Zimmerman, MD (The Curtis National Hand Center, Baltimore, MD), Alexander Spiess, MD (University of Pittsburgh Medical Center, Pittsburgh, PA),∗ Tahsin Acarturk, MD (University of Pittsburgh Medical Center, Pittsburgh, PA), Mario Solari, MD (University of Pittsburgh Medical Center, Pittsburgh, PA), Gregory A. Merrell, MD (Indiana Hand to Shoulder Center, Indianapolis, IN),∗ Jeffrey Greenberg, MD (Indiana Hand to Shoulder Center, Indianapolis, IN), Nicholas Crosby, MD (Indiana Hand to Shoulder Center, Indianapolis, IN), Reed Hoyer, MD (Indiana Hand to Shoulder Center, Indianapolis, IN), F. Thomas Kaplan, MD (Indiana Hand to Shoulder Center, Indianapolis, IN), Brandon Smetana, MD (Indiana Hand to Shoulder Center, Indianapolis, IN), Fraser Leversedge, MD (Duke University Medical Center, Durham, NC),∗ David Ruch, MD (Duke University Medical Center, Durham, NC),∗ Detlev Erdmann, MD (Duke University Medical Center, Durham, NC), Suhail Mithani, MD (Duke University Medical Center, Durham, NC), Marc Richard, MD (Duke University Medical Center, Durham, NC), Jason A. Nydick, DO (Florida Orthopaedic Institute, Tampa, FL),∗ Alfred Hess, MD (Florida Orthopaedic Institute, Tampa, FL), Jeffrey Stone, MD (Florida Orthopaedic Institute, Tampa, FL), Michael Garcia, MD (Florida Orthopaedic Institute, Tampa, FL), David Chen, MD (University of Miami, Miami, FL),∗ Helen Hui-Chou, MD (University of Miami, Miami, FL), Patrick Owens, MD (University of Miami, Miami, FL), Morad Askari, MD (University of Miami, Miami, FL), Seth Dodds, MD (University of Miami, Miami, FL), Asif Ilyas, MD (Rothman Institute, Philadelphia, PA),∗ Charles Leinberry Jr. MD (Rothman Institute, Philadelphia, PA), Christopher Jones, MD (Rothman Institute, Philadelphia, PA), Mark Wang, MD (Rothman Institute, Philadelphia, PA), Frederic Liss, MD (Rothman Institute, Philadelphia, PA), Michael Rivlin, MD (Rothman Institute, Philadelphia, PA), Robert Matthias, MD (University of Florida Health, Gainsville, FL),∗ Chung Chan, MD (University of Florida Health, Gainsville, FL), Thomas Wright, Jr. MD (University of Florida Health, Gainsville, FL), Kenneth Taylor Jr. MD, FAOA (Penn State Health, Hersey, PA),∗ Michael Darowish, MD (Penn State Health, Hersey, PA), Alexander Payatakes, MD (Penn State Health, Hersey, PA), Randy Hauck, MD (Penn State Health, Hersey, PA), Alan Koester, MD, CIME, MA (Marshall University Medical Center, Huntington, WV),∗ Steven Novotny, MD (Marshall University Medical Center, Huntington, WV), Colby Young, MD, MBA (Hand Surgery Specialists of Nevada, Las Vegas, NV),∗ Jedediah Jones, MD (Hand Surgery Specialists of Nevada, Las Vegas, NV), David Fadell, DO (Hand Surgery Specialists of Nevada, Las Vegas, NV), Carl Williams, MD (Hand Surgery Specialists of Nevada, Las Vegas, NV), Daniel Kokmeyer, MD (Hand Surgery Specialists of Nevada, Las Vegas, NV), Tsz Kit Kevin Chan, MD, MSc, FRCSC (Spectrum Health Grand Rapids, Grand Rapids, MI),∗ Jacqueline Geissler, MD (Hennepin County Medical Center, Minneapolis, MN),∗ and Thomas Varecka, MD (Hennepin County Medical Center, Minneapolis, MN).”
| Funders | Funder number |
|---|---|
| Brent DeGeorge | |
| Curtis National Hand Center, Baltimore, MD | |
| FACS | |
| FAOA | |
| Fraser Leversedge | |
| University of Kentucky Medical Center | |
| Hallym University Medical Center |
Keywords
- Conduits
- digital nerves
- nerve graft
- nerve repair
- processed acellular nerve allograft
ASJC Scopus subject areas
- Surgery
- Orthopedics and Sports Medicine