| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01809002 | Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair | PHASE3 | COMPLETED | 220 | — | — | Jun 1, 2015 | Aug 30, 2021 | Jul 12, 2023 | 21 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Processed Nerve Allograft | EXPERIMENTAL | Processed Nerve Allograft |
| Collagen Nerve Cuff | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Processed Nerve Allograft (human) | BIOLOGICAL | - |
| Collagen Nerve Cuff | DEVICE | Bovine collagen based nerve cuff |
Inclusion Criteria: * Peripheral Nerve Injury Exclusion Criteria: * Peripheral Neuropathy * Allergic to Bovine products such as Bovine Collagen Nerve Cuff