Active — Not RecruitingNot Applicable

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

United States3,126 participantsStarted 2008-11

Plain-language summary

This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Undergo post mastectomy autologous breast reconstruction with one ty…

What they're measuring

Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events

Timeframe: Through study completion or until lost to follow-up, approximately 3 years

RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery

Timeframe: Through study completion or until lost to follow-up, approximately 3 years

RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery

Timeframe: Through study completion or until lost to follow-up, approximately 3 years

Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction

Timeframe: Through study completion or until lost to follow-up, approximately 3 years

Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction

Timeframe: Through study completion or until lost to follow-up, approximately 3 years

Incidence of conduit, autograft, or procedure related adverse events

Timeframe: Through study completion or until lost to follow-up, approximately 3 years

Trial details

NCT IDNCT01526681

SponsorAxogen Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-11

View on ClinicalTrials.gov More Peripheral Nerve Injuries trials