what the data shows: comparability of allograft vs. autograft nerve repair
Data continues to confirm the comparability of outcomes and procedure costs for allograft and autograft nerve repair and supports allograft as a new standard of care.
In a first-of-its-kind publication, authors examined data from 1,550+ nerve repairs through a comprehensive, systematic literature review to statistically compare meaningful recovery (MR) rates between allograft, autograft and conduit repair using meta-analysis methodology. Results showed allograft and autograft repair are comparable across all nerve types and gap lengths up to 70 mm.
With no donor site comorbidities, or time requirement to harvest an autograft nerve, allograft has proven to be an effective, efficient standard of care.1
- motor
- sensory
meaningful recovery in mixed-motor nerve repair
- allograft
- autograft
- allograft
- autograft
There were no significant differences in MR or higher threshold MR between autograft and allograft across both short and long gaps.1
- allograft
- autograft
higher-threshold sensory
outcomes (MRCC ≥ S3+)
- allograft
- autograft
- allograft
- autograft
- conduit
There were no significant differences in MR or higher-threshold MR between autograft and allograft across both short and long gaps.
However, meaningful sensory recovery rates for both autograft and allograft were significantly better than for conduit in short gap sensory nerve repairs, the only repairs in which conduits were used in the literature.1
comparative effectiveness of allografts, autografts and conduits – study design
Authors: Jonathan Lans, Kyle R Eberlin, Peter J Evans, Deana Mercer, Jeffrey A Greenberg, Joseph F Styron
Methods: The search was conducted in MEDLINE from January of 1980 to March of 2020, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Included studies reported nerve injury type, repair type, gap length and outcomes for MR rates.
Thirty-five studies with 1,559 nerve repairs were identified.
- Autograft repair (21 studies, 670 repairs)
- Allograft (9 studies, 711 repairs)
- Conduit repair (7 studies, 178 repairs)
Background: Ideal nerve repair involves tensionless direct repair, which may not be possible after resection. Bridging materials include nerve autograft, allograft or conduit. This study aimed to perform a systematic literature review and meta-analysis to compare the meaningful recovery (MR) rates and postoperative complications following autograft, allograft and conduit repairs in nerve gaps greater than 5 mm and less than 70 mm. A secondary aim was to perform a comparison of procedure costs.
Selected article, Plastic Reconstructive Surgery Journal Club, May 2023
82%
MR achieved across sensory, mixed and motor allograft nerve repairs in gaps up to 70 mm. No related adverse events were reported.*2
*This data was also included in the above meta-analysis
80%
of patients had an improvement in pain following excision of a neuroma and allograft reconstruction.3
100%
of pediatric patients who underwent postoperative Semmes-Weinstein monofilament testing demonstrated partial return of sensation after free fibula mandible reconstruction4
A recent study of 1,363 cases showed total costs between allograft and autograft nerve repairs were similar in both the outpatient and inpatient setting. However, time spent in the OR was less for allograft nerve repair procedures.5
- OR costs
- inpatient
- outpatient
costs
- allograft
- autograft
The total costs for allograft repair were less than or similar to autograft repair in inpatient or outpatient settings.
Allograft requires less time overall, opening up OR time for additional procedures.5
- allograft (N = 80)
- autograft (N = 22)
In the inpatient setting, allograft and autograft costs are comparable. Allograft implant cost is offset by the additional OR time autograft requires.6
- allograft (N = 1041)
- autograft (N = 247)
Procedure operating room (OR) costs and time were significantly higher for autograft in the outpatient setting.
While allograft nerve includes a higher implant cost, the implant cost is offset by the additional procedure OR costs required in an autograft reconstruction rendering comparable costs for both procedures.6
procedure costs of peripheral nerve graft reconstruction – study design
Authors: Noah M Raizman MD, Ryan D Endress MD, Joseph F Styron, MD, PhD, Seth L Emont, PhD, MS, Zhun Cao, PhD, Lawrence I Park, MBA, MPH, Jeffery A Greenberg MD.
Methods: This paper is a retrospective cross-sectional observational study using the US all-payer PINC AI™ Healthcare Database (Premier Healthcare Database) that examined facility procedure costs and cost drivers in patients undergoing allograft or autograft repair of an isolated single peripheral nerve injury between January 2018 and August 2020. The Premier Healthcare Database is a United States hospital-based, all-payer, geographically diverse administrative database that includes data from one in every five hospital discharges in the United States.
Background: Peripheral nerve injuries not repaired in an effective and timely manner may lead to permanent functional loss and/or pain. For gaps greater than 5 mm, autograft has been the gold standard. Allograft has recently emerged as an attractive alternative, delivering comparable functional recovery without risk of second surgical site morbidities. Cost is an important factor when considering surgical options, and with a paucity of nerve repair cost data, this study aimed to compare allograft and autograft procedure costs.
In addition to increased OR procedure time and associated costs, complications at the harvest site can negatively affect quality of life long after surgery has occurred.
Allograft nerve repair avoids the additional surgical procedure, eliminating the morbidities of an autograft nerve reconstruction and decreases time spent in the OR. This opens up additional time for other procedures to take place.
Autograft nerve repair has the potential for persistent chronic postoperative morbidities, as detailed in the study below.6
sural nerve grafting
Allograft nerve reconstruction avoids an additional surgical procedure and associated morbidities such as pain, sensory loss and functional impairment.
Eliminating the time needed for autograft harvest and a secondary surgery site decreases the overall time spent in the OR.
donor site morbidity after sural nerve grafting – study design
Authors: Ravinder Bamba, Scott N Loewenstein, Joshua M Adkinson
Methods: A systematic review of literature was conducted to identify studies that examined donor site outcomes of sural nerve graft harvests.
Background: Understanding the morbidity of sural nerve harvest is important when counseling patients regarding nerve grafts. Existing data consist of small studies with varying degrees of follow-up and a wide range of reported donor site outcomes. The objective of this study was to systematically review the literature and pool the current data for postoperative outcomes after sural nerve graft harvest.
Nerve repair solutions are extensively studied. Our bibliography contains publications across a variety of nerve repair solutions and applications throughout the body. Axogen is providing this bibliography for awareness and educational purposes. New publications are added continuously. The bibliography does not claim to be complete.
There’s only a short form between you and our nerve product team who can help you get more information about our nerve repair solutions.
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the RANGER® study
A multicenter, retrospective study of Avance® Nerve Graft utilization, evaluations and outcomes in peripheral nerve injury repair (RANGER). The RANGER study, the Avance Nerve Graft registry, has completed the second data milestone and continues to enroll.
the REPOSE-XL℠ study
The REPOSE-XL study is a multicenter, prospective single cohort pilot study intended to evaluate the use of Axoguard Nerve Cap® in large diameter sizes to protect and preserve terminated nerve ends after limb trauma or amputation to optimize subsequent reconstructive procedures. This study is supported, in part, with funding by a grant from the United States Department of Defense peer reviewed Orthopedic Research Program. This study is actively enrolling.
the RECON℠ study
A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities (RECON), is a Phase 3 clinical trial developed under a Special Protocol Assessment to support the transition of Avance to a licensed biologic. Enrollment and subject follow-up are completed
the MATCH® study
A contemporary cohort control for the RANGER study, MATCH provides outcomes data for nerve autograft and manufactured conduit repairs from participating registry centers. MATCH data milestones have been presented and the cohorts are actively enrolling.
REPOSE®
A prospective randomized controlled study to assess the impact of Axoguard Nerve Cap® in the management of painful neuroma as compared to standard neurectomy. REPOSE is actively enrolling.
Sensation-NOW®
Sensation Neurotization Outcomes for Women, or Sensation-NOW, is an arm of the RANGER study focused on the breast neurotization procedure and the impact of restoration of sensory function. Sensation-NOW is actively enrolling.
Rethink Pain™
Rethink Pain is an observational registry study that will evaluate the patient’s healthcare journey and pain history through detailed medical history and record review. For patients who undergo surgical treatment for pain, the registry will capture standardized outcomes measures to assess key factors such as post-operative pain, pain medication usage, quality of life outcomes, and functional outcome of associated nerves as compared to pre-operative levels. This study is actively enrolling.
references
*Nerve graft peripheral nerve repair excludes breast, OMF, neurectomy and other nerve repair types (e.g., conduit direct); n = 918 outpatient and n = 697 inpatient exclusions
- Lans J, et al. A systematic review and meta-analysis of nerve gap repair: comparative effectiveness of allografts, autografts, and conduits. Plast Reconstr Surg. 2023 May 1;151(5):814e-827e. doi: 10.1097/PRS.0000000000010088. Epub 2022 Dec 26.
- Safa B, et al. Peripheral nerve repair throughout the body with processed nerve allografts: Results from a large multicenter study. Microsurgery. 2020;40(5):527-537. doi:10.1002/micr.30574
- Jain SA, et al. Clinical outcomes of symptomatic neuroma resection and reconstruction with processed nerve allograft. Plast Reconstr Surg Glob Open. 2021;9(10):e3832. Published 2021 Oct 4. doi:10.1097/GOX.0000000000003832
- Kaplan J, et al. Sensory outcomes for inferior alveolar nerve reconstruction with allograft following free fibula mandible reconstruction. Plast Reconstr Surg. 2023;152(3):499e-506e. doi:10.1097/PRS.0000000000010286
- Raizman NM, et al. Procedure costs of peripheral nerve graft reconstruction. Plast Reconstr Surg Glob Open. 2023;11(4):e4908. Published 2023 Apr 10. doi:10.1097/GOX.0000000000004908
- Bamba R, et al. Donor site morbidity after sural nerve grafting: A systematic review. J Plast Reconstr Aesthet Surg. 2021;74(11):3055-3060. doi:10.1016/j.bjps.2021.03.096