Last updated on May 2019

Registry of Avance Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Peripheral Nerve Injuries
  • Age: - 100 Years
  • Gender: Male or Female

Primary Study Criteria (RANGER Avance):

Inclusion Criteria:

  • Males and Females who have undergone nerve repair using the Avance Nerve Graft for the repair of a nerve injury
  • Returned for at least one post-operative follow-up visit

Exclusion Criteria:

Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up.

Addendum 1 (MATCH) Criteria:

Inclusion Criteria:

  • Have nerve transection injuries to the upper extremity;
  • Have undergone tension free end to end nerve coaptation on both the proximal and distal portion of the nerve gap with nerve autograft or nerve entubulation with nerve tube conduit at a participating ANG-CP-005 registry site after 2004 and;
  • Have completed sufficient follow-up assessments at a regeneration rate of 2mm/day to determine the outcomes of the repair or is willing to comply with site specific post-operative care procedures and assessments to determine the outcome of the repair.

Exclusion Criteria:

  • Direct nerve repairs;
  • Nerve gaps greater than 70mm;
  • Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions;
  • Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.

Addendum 2 (Sensation-NOW) Criteria:

Inclusion Criteria:

  • Female 18 years old;
  • Undergone post mastectomy autologous breast reconstruction within the last 18 months;
  • Able to provide informed consent and are willing to comply with post-operative care procedures and assessments.

Exclusion Criteria:

  • Secondary neurotization revision surgery for partial or total flap loss;
  • Expected use of medication during the study that is known to impact nerve regeneration or to cause peripheral neuropathy;
  • Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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