NCT01809002

Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Axogen Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Nerve Discontinuities

Interventions

Type	Name	Description
BIOLOGICAL	Processed Nerve Allograft (human)
DEVICE	Collagen Nerve Cuff	Bovine collagen based nerve cuff

Timeline

• Start date: 2015-06-01
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2013-03-12
• Last updated: 2023-07-12
• Results posted: 2023-07-12

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study