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Peripheral Nerve Repair Throughout the Body with Processed Nerve Allografts: Results from a Large Multicenter Study

·Microsurgery·2020·127 citations·Hand & Upper
Free Full Text·DOI·PubMed
SummaryAbstract on PubMed →

This multicenter registry study (RANGER) reports outcomes for 624 peripheral nerve repairs using processed nerve allograft (Avance) across 31 centers over 10 years. The central question: can processed nerve allograft achieve meaningful recovery comparable to autograft, across nerve types and gap lengths up to 70 mm? The study provides the largest real-world outcomes dataset on this technique to date.

Study Snapshot

Design
Multicenter prospective registry
Setting: 31 study centers, multiple US sites
Funding: Industry (Axogen Corporation)
Objective
Whether processed nerve allograft achieves meaningful recovery across nerve types and gaps up to 70 mm.
Outcome(s)
Meaningful recovery (≥S3/M3 on MRCC scale) at adequate follow-up
Subjects
385 subjects, 624 nerve repairs with outcome data
Inclusion
  • Nerve repair with processed nerve allograft
  • Sufficient follow-up to determine repair outcome
  • Follow-up commensurate with reinnervation distance
Exclusion
  • Motor repair >1 year post-injury (chronic denervation)
  • Insufficient follow-up data to determine outcome
Follow-up
Mean 417 days (range 120–3,286)
Statistics
Mann Whitney U testFisher's exact testChi-square testBonferroni correction

Key Findings

  • Processed nerve allograft achieved 82% meaningful recovery (≥S3/M3) across sensory, mixed, and motor repairs in gaps up to 70 mm. Recovery by nerve type was 84% sensory, 71% mixed, and 83% motor — with no significant difference by nerve type in the upper extremity (p = .56). These rates were comparable to historical autograft data and exceeded conduit outcomes.
  • Gap length was a significant predictor only at the extremes: gaps under 15 mm achieved 91% meaningful recovery versus 69% for the 50–70 mm group (p = .011) in the upper extremity. The intermediate gap groups (15–29 mm, 85%; 30–49 mm, 78%) were not significantly different from each other. The long-gap group contained more complex injuries, which may partly explain the lower recovery rate.
  • Mechanism of injury significantly influenced recovery in the upper extremity: neuroma resections 94%, lacerations 85%, complex injuries 74% (p = .027). Complex mechanisms — amputation, avulsion, gunshot, crush — introduce biological variables beyond the nerve gap itself, a finding consistent with autograft reference data for these injury patterns.
  • Upper extremity meaningful recovery (83%) was significantly higher than lower extremity (53%) (p = .01). This pattern mirrors autograft historical data and likely reflects both longer regeneration distances and the specific nerves involved in lower extremity injuries (sciatic, peroneal).
  • Time to repair did NOT significantly affect outcomes: acute, delayed, and chronic repairs achieved 81%, 85%, and 83% meaningful recovery respectively (p = .93). Smoking status also showed no significant effect. This supports flexibility in surgical timing without penalty to the allograft approach.
  • At higher recovery thresholds (≥S3+), PNA digital nerve repairs achieved 83% — exceeding autograft (70%) and conduit (66%) from reference data. This suggests that for short-gap digital nerve injuries, allograft may offer an advantage over conduit and is at least equivalent to autograft, without donor site morbidity.
  • The safety profile was favorable. No adverse events were attributed to the allograft product. Overall adverse event incidence (3.7% by subject) fell within the expected range for peripheral nerve surgical procedures (2.1–8.6% in reference data). No communicable disease transmissions were reported.
Board PearlProcessed nerve allograft achieves 82% meaningful recovery in gaps up to 70 mm — comparable to autograft, far exceeding conduit (limited to gaps under 10 mm).

Clinical Relevance

When counseling a patient about nerve gap repair, the choice between autograft, conduit, and processed nerve allograft depends on gap length and injury type. Conduit is only appropriate for gaps under 10 mm — outside that range, outcomes are highly variable and the evidence does not support its use.

Processed nerve allograft achieves 82% meaningful recovery in gaps up to 70 mm, comparable to historical autograft data, without donor site morbidity, additional surgical sites, or the need for immunosuppression.

Two variables most reliably predict worse outcomes: complex injury mechanism (74% vs 94% for neuroma resections) and longer gap lengths (69% at 50–70 mm vs 91% at under 15 mm). When you see a crush or blast injury with a long gap, counsel patients accordingly — this is a biology problem, not just a gap problem.

Timing is more flexible than previously assumed: chronic repairs (repaired more than 90 days out) achieved 83% meaningful recovery, not significantly different from acute repairs. However, motor nerve repairs older than one year after injury were excluded from analysis due to chronic denervation effects — so the flexibility in timing applies to sensory and mixed repairs more than pure motor reconstruction.

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|

Peripheral Nerve Repair Throughout the Body with Processed Nerve Allografts: Results from a Large Multicenter Study

·Microsurgery·2020·127 citations·Hand & Upper
Free Full Text·DOI·PubMed
SummaryAbstract on PubMed →

This multicenter registry study (RANGER) reports outcomes for 624 peripheral nerve repairs using processed nerve allograft (Avance) across 31 centers over 10 years. The central question: can processed nerve allograft achieve meaningful recovery comparable to autograft, across nerve types and gap lengths up to 70 mm? The study provides the largest real-world outcomes dataset on this technique to date.

Study Snapshot

Design
Multicenter prospective registry
Setting: 31 study centers, multiple US sites
Funding: Industry (Axogen Corporation)
Objective
Whether processed nerve allograft achieves meaningful recovery across nerve types and gaps up to 70 mm.
Outcome(s)
Meaningful recovery (≥S3/M3 on MRCC scale) at adequate follow-up
Subjects
385 subjects, 624 nerve repairs with outcome data
Inclusion
  • Nerve repair with processed nerve allograft
  • Sufficient follow-up to determine repair outcome
  • Follow-up commensurate with reinnervation distance
Exclusion
  • Motor repair >1 year post-injury (chronic denervation)
  • Insufficient follow-up data to determine outcome
Follow-up
Mean 417 days (range 120–3,286)
Statistics
Mann Whitney U testFisher's exact testChi-square testBonferroni correction

Key Findings

  • Processed nerve allograft achieved 82% meaningful recovery (≥S3/M3) across sensory, mixed, and motor repairs in gaps up to 70 mm. Recovery by nerve type was 84% sensory, 71% mixed, and 83% motor — with no significant difference by nerve type in the upper extremity (p = .56). These rates were comparable to historical autograft data and exceeded conduit outcomes.
  • Gap length was a significant predictor only at the extremes: gaps under 15 mm achieved 91% meaningful recovery versus 69% for the 50–70 mm group (p = .011) in the upper extremity. The intermediate gap groups (15–29 mm, 85%; 30–49 mm, 78%) were not significantly different from each other. The long-gap group contained more complex injuries, which may partly explain the lower recovery rate.
  • Mechanism of injury significantly influenced recovery in the upper extremity: neuroma resections 94%, lacerations 85%, complex injuries 74% (p = .027). Complex mechanisms — amputation, avulsion, gunshot, crush — introduce biological variables beyond the nerve gap itself, a finding consistent with autograft reference data for these injury patterns.
  • Upper extremity meaningful recovery (83%) was significantly higher than lower extremity (53%) (p = .01). This pattern mirrors autograft historical data and likely reflects both longer regeneration distances and the specific nerves involved in lower extremity injuries (sciatic, peroneal).
  • Time to repair did NOT significantly affect outcomes: acute, delayed, and chronic repairs achieved 81%, 85%, and 83% meaningful recovery respectively (p = .93). Smoking status also showed no significant effect. This supports flexibility in surgical timing without penalty to the allograft approach.
  • At higher recovery thresholds (≥S3+), PNA digital nerve repairs achieved 83% — exceeding autograft (70%) and conduit (66%) from reference data. This suggests that for short-gap digital nerve injuries, allograft may offer an advantage over conduit and is at least equivalent to autograft, without donor site morbidity.
  • The safety profile was favorable. No adverse events were attributed to the allograft product. Overall adverse event incidence (3.7% by subject) fell within the expected range for peripheral nerve surgical procedures (2.1–8.6% in reference data). No communicable disease transmissions were reported.
Board PearlProcessed nerve allograft achieves 82% meaningful recovery in gaps up to 70 mm — comparable to autograft, far exceeding conduit (limited to gaps under 10 mm).

Clinical Relevance

When counseling a patient about nerve gap repair, the choice between autograft, conduit, and processed nerve allograft depends on gap length and injury type. Conduit is only appropriate for gaps under 10 mm — outside that range, outcomes are highly variable and the evidence does not support its use.

Processed nerve allograft achieves 82% meaningful recovery in gaps up to 70 mm, comparable to historical autograft data, without donor site morbidity, additional surgical sites, or the need for immunosuppression.

Two variables most reliably predict worse outcomes: complex injury mechanism (74% vs 94% for neuroma resections) and longer gap lengths (69% at 50–70 mm vs 91% at under 15 mm). When you see a crush or blast injury with a long gap, counsel patients accordingly — this is a biology problem, not just a gap problem.

Timing is more flexible than previously assumed: chronic repairs (repaired more than 90 days out) achieved 83% meaningful recovery, not significantly different from acute repairs. However, motor nerve repairs older than one year after injury were excluded from analysis due to chronic denervation effects — so the flexibility in timing applies to sensory and mixed repairs more than pure motor reconstruction.

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