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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Axogen Corporation
- Enrollment
- 220
- Locations
- 42
- Primary Endpoint
- Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Peripheral Nerve Injury
Exclusion Criteria
- •Peripheral Neuropathy
- •Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Outcomes
Primary Outcomes
Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
Time Frame: Month 12
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
Static Two-Point Discrimination (Data As-reported)
Time Frame: Up to Month 12
s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
Secondary Outcomes
- Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)(Month 12)
- Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)(Month 12)
- Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)(Month 12)
- Time to Recovery of s2PD (Data As-reported)(Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op))
- Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)(Month 12)