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RECON Study for Hand Nerve Injury - Clinical Trial

What is the Purpose of this Study?

The purpose of this study is to compare two nerve repair treatments.

What is the Condition Being Studied?

Hand nerve injury

Who Can Participate in the Study?

Adult patients age 18 to 65 who need to have hand nerve injury repair

Age Group
Adults

What is Involved?

If you need to have hand nerve injury surgery and choose to join the study, you will be randomly (like a flip of a coin) assigned to receive one of two FDA-approved treatments for nerve repair during the operation:
- NeuraGen Nerve Guide or
- Avance Nerve Graft
You will not know which treatment you received.
You will remain in the study for 1 year.
After surgery you will need to return for five follow-up visits to have your hand evaluated and photographed and to answer some questionnaires.

Study Details

Full Title
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 (RECON)
Principal Investigator
Hand and Upper Extremity Surgeon
Protocol Number
IRB:PRO00068821
NCT:NCT01809002
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698