Ortho Research

Clinical Trials

AxoGen Nerve Graft

Contact

Christiana Booher

434-243-0296

clb6xx@hscmail.mcc.virginia.edu

IRB-HSR 18228

Clinic Visit Registration: 18228-Deal

Inclusion Criteria

  • Subjects 18 to 65 years of age, inclusive;
  • Require primary or secondary nerve injury repair with nerve cuff (NeuraGen® Nerve Guide a Type 1 bovine collagen nerve cuff) or Avance® Nerve Graft in at least 1 digital nerve;
  • One of injury to nerve must be resectable;
  • Nerve gaps following resection, between 5 and 25 mm, inclusive;
  • Undergo tension free end to end nerve to nerve coaptation on both the proximal and distal portion of the nerve gap in the Avance® Nerve Graft Group or nerve entubulation in the Nerve Cuff group;
  • Have an uninjured contralateral or adjacent digit that is suitable to serve as a referenced digit for baseline functional assessments;
  • Be willing and able 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.

Exclusion Criteria

  • Estimated distance of regeneration of >150 mm (distance from proximal injury site to tip of target digit);
  • Injuries distal to the distal interphalengeal joint;
  • Extensive soft tissue injury which will impair recovery assessment;
  • Incomplete nerve transections;
  • Injury requiring replantation of target digit;
  • Injuries to the affected nerve proximal to the superficial palmar arch;
  • Nerve injuries >24 weeks post initial injury;
  • End to side nerve repair;
  • Injuries with vascular damage resulting in inadequate perfusion despite repair;
  • Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy;
  • Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system;
  • Use of bovine collagen-based nerve conduit in a subject with known or suspected bovine sensitivity;
  • History of neuropathy, diabetic neuropathy or any other known neuropathy;
  • Currently enrolled in another investigational study;
  • Expected use of medication during the study that is known to impact nerve regeneration or to cause peripheral neuropathy;
  • History of chronic ischemic condition of the upper extremity; and
  • Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.

Study Summary

  • Visit 1: Screening/Baseline assessment ≤ 42 days preoperatively: Clinic visit
  • Visit 2: Operative day
  • Visit 3: 1 month ±14 days Clinic visit
  • Visit 4: 3 months ±14 days Clinic visit
  • Visit 5: 6 months ±14 days Clinic visit
  • Visit 6: 9 months ±14 days Clinic visit
  • Visit 7: 12 months ±14 days Clinic visit

Baseline Visit

  • Consent, Relevant Medical History, Demographics, Sensory Assessments, Pain Assessments (VAS), Quality of Life Questionnaires, CISS, Review Current Treatments

Surgery Day

  • Traumatic Injury History, Operative Information, Randomization, Physician Satisfaction Survey, Economic Questionnaires, Review Current Treatments, Review health-related problems

1, 3, 6, 9 month visit

  • Sensory Assessments, Pain Assessment (VAS), Quality of Life Questionnaires, Subject Satisfaction Questionnaire, Review Current Treatments, Review heath-realted problems

12 month visit

  • All of the same as the previous follow-up visits and the Subject Blinding Questionnaire

Payment

  • $50/follow up visit (5 total)
  • Complete vendor registration through UVA Procurement at: https://www.procurement.virginia.edu/pagevendorregistrationform
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