Phase 3
Completed N=220
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Peripheral Nerve Discontinuities
Source: ClinicalTrials.gov NCT01809002 ↗
Enrolled (actual)
220
Serious AEs
3.6%
Results posted
Jul 2023
Primary outcomePrimary: Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach) — 9.1; 9.3 Millimeters
◆ Published Evidence
Not yet cited
0citations
Digital Nerve Repair With Flexor Tendon Injury: Conduits are Less Effective.
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.
Linked Publications
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Digital Nerve Repair With Flexor Tendon Injury: Conduits are Less Effective.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.