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

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ClinicalTrials.gov Identifier: NCT01526681
Recruitment Status : Recruiting
First Posted : February 6, 2012
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Axogen Corporation

Brief 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.

Condition or disease Intervention/treatment
Peripheral Nerve Injuries Other: Processed Human Nerve Graft Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc. Other: Autogenous Nerve Graft Device: Nerve Tube Conduit Procedure: Autologous Breast Reconstruction with Neurotization Procedure: Autologous Breast Reconstruction without Neurotization

Detailed Description:

This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft.

Addendum 1 (MATCH) establishes a comparative arm to collect data on nerve injuries repaired with nerve autografts and nerve tube conduits at select RANGER® participating sites.

Addendum 2 (Sensation-NOW) establishes a focused arm to collect data on autologous breast reconstructive procedures where neurotization was completed. Post-mastectomy autologous breast reconstruction procedures without neurotization will serve as an internal control group to allow for comparisons.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair
Study Start Date : November 2008
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RANGER: Avance Nerve Graft
Processed Human Nerve Graft
Other: Processed Human Nerve Graft
Implantation of appropriate length of processed human nerve graft at the time of surgery

Historical Control for Standard Treatment
Literature review for outcomes from standard treatments, i.e. Autogenous Nerve Graft.
Other: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.
Historical control from established literature

MATCH Arm: Contemporary Control
Addendum 1: Autogenous Nerve Graft and Nerve Tube Conduit
Other: Autogenous Nerve Graft
Nerve gap reconstructions with autogenous nerve graft within the upper extremity

Device: Nerve Tube Conduit
Nerve gap reconstructions with nerve tube conduit within the upper extremity

Sensation-NOW Arm: Breast Neurotization
Addendum 2: Post-mastectomy autologous breast reconstruction with or without neurotization
Procedure: Autologous Breast Reconstruction with Neurotization
Procedure: Autologous Breast Reconstruction without Neurotization



Primary Outcome Measures :
  1. Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.

  2. RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for a change in sensory function, if applicable, of the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care sensory assessments or until lost to follow-up.

  3. RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for a change in motor function, if applicable, to the reconstructed peripheral nerve through the course of their follow-up using Physician's standard of care motor assessments or until lost to follow-up.

  4. Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for change in sensation through the course of their recovery using Physician's standard of care assessments or until lost to follow-up. Standard of care sensory assessments may include evaluation using a neurosensory testing device or Semmes Weinstein Monofilaments measured in g/mm2.

  5. Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for change in quality of life as measured by Breast Q through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented.

  6. Incidence of conduit, autograft, or procedure related adverse events [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed through the course of their recovery based on Physician's standard of care practice or until lost to follow-up.


Secondary Outcome Measures :
  1. Pain Level [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for a change in pain level as measured by VAS, when available, through the course of their recovery using Physician's standard of care assessments for pain or until lost to follow-up.

  2. RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for change in quality of life as measured by Disabilities of the Arm Shoulder and Hand Questionnaire (DASH), if available, through the course of their recovery or until lost to follow-up using Physician's standard of care assessments. Standard of care assessments may include evaluation of quality of life via other scales or may be qualitatively documented.

  3. Cost of Care [ Time Frame: Through study completion or until lost to follow-up, approximately 3 years ]
    Participants will be followed for cost of care, as converted to USD, from the surgical nerve procedure through the course of their recovery or until lost to follow-up using available data in the medical record from Physician's standard of care.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects surgically repaired with Avance Nerve Graft to reconstruct peripheral nerve discontinuities.
Criteria

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 type of autologous flap (no stacked reconstructions or use of implant with autologous flap)
  • Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest
  • Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction:

    • Breast-Q Physical Well Being of the Chest
    • Breast-Q Satisfaction with Breast
    • Breast-Q Physical Well Being of the Abdomen
    • Breast-Q Abnormal Breast Sensations
    • Breast-Q Impact of Breast Sensation on Quality of Life
    • Breast-Q Return of Breast Sensation
  • Able to provide informed consent and are willing to comply with post-operative care procedures and assessments

Exclusion Criteria:

  • Surgical history of secondary revision surgery for partial or total flap loss
  • Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
  • Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
  • Currently undergoing IV chemotherapy or radiation
  • Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule

Additional Eligibility criteria to Modules

Module 1: Native Skin Reconstructions with and without neurotization.

  • Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region.
  • Sensory assessments must be completed on ≥ 8 Zones of Native Skin.

    • Center zone measurement may be on either Native Skin or Flap Skin.
    • All Inner and Outer zone measurements must be on Native Skin.
    • De-identified photo of the breast reconstruction with 9 zones identified.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526681


Contacts
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Contact: Stacy Arnold 386-462-6800 clinicalresearch@axogeninc.com

Locations
Show Show 41 study locations
Sponsors and Collaborators
Axogen Corporation
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Responsible Party: Axogen Corporation
ClinicalTrials.gov Identifier: NCT01526681    
Other Study ID Numbers: ANG-CP-005
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axogen Corporation:
Sensory Nerve
Mixed Nerve
Motor Nerve
Neurotization
Nerve Injury
Peripheral Nerve Injury
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System