Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON)

Axogen

Status and phase: Completed; Phase 3

Conditions: Peripheral Nerve Discontinuities

Treatments: Biological: Processed Nerve Allograft (human); Device: Collagen Nerve Cuff

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809002

ANG-CP-007

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peripheral Nerve Injury

Exclusion criteria

• Peripheral Neuropathy
• Allergic to Bovine products such as Bovine Collagen Nerve Cuff

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Processed Nerve Allograft

Experimental group

Description:

Processed Nerve Allograft

Treatment:

Biological: Processed Nerve Allograft (human)

Collagen Nerve Cuff

Active Comparator group

Treatment:

Device: Collagen Nerve Cuff