RANGER Registry – peripheral nerve injury and repair
Research type
Research Study
Full title
A Multicenter Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair.
IRAS ID
219720
Contact name
Dominic Power
Contact email
Sponsor organisation
AxoGen, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This study proposes to collect data regarding the use and outcomes of Avance® Nerve Graft in repair of peripheral nerve gap injuries. The MATCH addendum proposes to collect data on an additional cohort of patients who have other methods of repair of peripheral nerve gap injuries (conduit repair and autograft repair). This data will be anonymised and collated in an international registry and later used to assess the effectiveness of nerve allograft in repairing peripheral nerve gap injuries and to compare it to the other methods currently in use.
This is of importance as although all three methods of repair are used in current clinical practice there is no consensus regarding the best method of peripheral nerve gap repair.
Eligible subjects will include male and female subjects who have had surgical repair with the Avance® Nerve Graft, nerve autograft or nerve tube conduit after 2004 for nerve gap injury.
Data for this study will be collected at multiple hospital sites within the United Kingdom. These sites will include NHS hospitals where peripheral nerve gap repair surgery is performed. Data will be anonymised and added to an international registry that will contain data from up to 100 US, UK and other International sites.
This study will enroll up to 2500 total RANGER and 500 total MATCH subjects from the participating sites. For prospective patients data will be collected from available medical records obtained during standard admission and postoperative follow up (≥4 postoperative visits). For retrospective patients data will be collected from available medical records and also from an optional additional follow up outpatient visit. This optional additional appointment will be the only patient interaction performed in addition to standard treatment.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
17/NW/0640
Date of REC Opinion
7 Dec 2017
REC opinion
Further Information Favourable Opinion