Stopped: Axogen suspended market availability of the Avive® Soft Tissue Membrane effective June 1, 2021. This decision was not related to any safety concerns or product quality issues.
A registry study to evaluate the role of Avive® Soft Tissue Membrane in the management of nerve injury associated with acute trauma in the upper extremity.
Age range
5 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only).
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in PROMIS Pediatric Upper Extremity/Parent Proxy Upper Extremity (PUE/PPUE) outcomes assessment at 2,4,8,12,16, 24, and 52 post-operative weeks (Pediatric subjects only)
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Visual Analogue Scale (VAS) For Pain Score at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in Reported Pain Using the Faces Pain Scale-Revised Scale (FPS-R) assessment at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in patient reported health status Using SF-36 patient reported health survey at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Changes in KINDL Health-Related Quality of Life questionnaire for children at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Patient Rated Wrist Evaluation
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Sensory Function as measured by Medical Research Council Classification (MRCC) for Sensory Recovery
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Motor Function as measured by Medical Research Council Classification (MRCC) for Motor Recovery
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Motor Function as measured by Grip and Pinch Strength
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Motor Function as measured by Range of Motion
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Change in Tinel's Sign
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Incidence of Adverse Events Associated with the Placement of Avive Soft Tissue Membrane
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks
Health Care Economic Impact based on Resource Utilization and Associated Costs
Timeframe: 2, 4, 8, 12, 16, 24, and 52 weeks