A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options (NCT00948025) | Clinical Trial Compass
TerminatedNot Applicable
A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options
Stopped: transitioning from 361 HCT/P Tissue to a Biologic (BLA)
United States23 participantsStarted 2009-06
Plain-language summary
This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCEâ„¢ in at least 1 digital nerve;
* Undergo End to End nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the AVANCEâ„¢ group or nerve entubulation in the Hollow Nerve Conduit group;
* Be willing to comply with all aspects of the treatment and evaluation schedule over a 12 Month duration; and
* Sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures.
Exclusion Criteria:
* Nerve gaps of \< 5 mm or \> 20 mm;
* Estimated distance of regeneration of \>125 mm (distance from injury site to sensory target)
* Nerve crush or avulsion injuries;
* Incomplete nerve transections;
* Injury requiring replantation of target digit;
* Contralateral digital injuries corresponding to the target digit;
* Nerve injuries in the affected limb proximal to the crease of the wrist;
* End to side nerve repair;
* Injuries with significant vascular damage which may impair adequate perfusion of the target limb;
* Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system;
* Use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity;
* Subjects age ≤18 years or ≥70 years;
* History neuropathy, diabetic or any other known neuropathy;
* Secondary ner…
What they're measuring
1
Recovery of Static 2-point Discrimination in the Affected Digit