Phase 3
N=220
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Peripheral Nerve Discontinuities
Bottom Line
View on ClinicalTrials.gov: NCT01809002 ↗Enrolled (actual)
220
Serious AEs
3.6%
Results posted
Jul 2023
Primary outcome: Primary: Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach) — 9.1; 9.3 Millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Processed Nerve Allograft (human) (Biological); Collagen Nerve Cuff (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Axogen Corporation
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach) |
9.1; 9.3 | — |
| PRIMARY Static Two-Point Discrimination (Data As-reported) |
7.3; 7.5; 6.1; 7.5 | 0.035 sig |
| SECONDARY Response Rate for Recovery of s2PD at Month 12 (Data As-Reported) |
77.5; 77.2 | 0.915 |
| SECONDARY Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach) |
54.46; 51.67 | — |
| SECONDARY Time to Recovery of s2PD (Data As-reported) |
8.0; 7.8 | 0.792 |
| SECONDARY Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported) |
4.0; 4.0 | 0.526 |
| SECONDARY Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach) |
-24.09; -24.94 | — |
Summary
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.
Eligibility Criteria
Inclusion Criteria
- Peripheral Nerve Injury
Exclusion Criteria
- Peripheral Neuropathy
- Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Data sourced from ClinicalTrials.gov (NCT01809002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.