A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction

Recruiting Phase 4 Interventional Study
Peripheral Nerve Injury Peripheral Nerve Discontinuity Mixed Peripheral Nerve Injury Motor Peripheral Nerve Injury Upper Extremity Nerve Injury
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
178 (estimated)
Sponsor
Axogen Corporation · Industry
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About This Trial

This is a multicenter, 1:1 randomized, prospective, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Study Participant Criteria 1. Be ≥ 18 years of age at the time of consent; 2. Willing and able to comply with all aspects of the treatment and evaluation schedule over a 24-month duration; 3. Provide documented Institutional Review Board (IRB)/Independent Ethics Committee (IEC)…
Contacts

Stacy Arnold

(386) 462-6800

clinicalresearch@axogeninc.com

CONTACT

Hayley Nicolosi

(386) 462-6800

hnicolosi@axogeninc.com

CONTACT