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

Sponsor

Axogen Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT01526681

Collaborator

(none)

5,000

Enrollment

Locations

205

Duration (Months)

111.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Avance Nerve Graft: Incidence of Avance Nerve Graft Related Adverse Events [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.
RANGER and MATCH: Sensory Function as measured by Medical Research Council Classification (MRCC) for sensory recovery [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.
RANGER and MATCH: Motor Function as measured by Medical Research Council Classification (MRCC) for motor recovery [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.
Sensation-NOW- Breast Neurotization: Sensory Function Post Autologous Breast Reconstruction [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 assessment includes evaluation using Semmes Weinstein Monofilament kit measured in g/mm2.
Sensation-NOW- Breast Neurotization: Quality of Life Measurement Post Autologous Breast Reconstruction [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.
Incidence of conduit, autograft, or procedure related adverse events [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

Pain Level [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.
RANGER and/or MATCH: Quality of Life Following Reconstruction of Peripheral Nerve [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.
Cost of Care [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RANGER & MATCH: Arizona Center for Hand Surgery	Phoenix	Arizona	United States	85004
2	RANGER: Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
3	RANGER & MATCH: University of California - Irvine	Orange	California	United States	92868
4	RANGER & MATCH: The Buncke Clinic	San Francisco	California	United States	94114
5	Sensation-NOW: Stanford University	Stanford	California	United States	94305
6	Sensation-NOW: University of Colorado School of Medicine	Aurora	Colorado	United States	80045
7	MATCH: University of Miami	Miami	Florida	United States	33176
8	RANGER & MATCH: Florida Orthopaedic Institute	Tampa	Florida	United States	33609
9	RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta	Atlanta	Georgia	United States	30342
10	RANGER & MATCH: University of Kansas Medical Center	Kansas City	Kansas	United States	66160
11	Sensation-NOW: University of Kansas Medical Center	Kansas City	Kansas	United States	66160
12	RANGER: University of Kentucky	Lexington	Kentucky	United States	40506
13	Sensation-NOW: Advanced Reconstructive Care, LLC	Metairie	Louisiana	United States	70002
14	RANGER: Johns Hopkins University	Baltimore	Maryland	United States	21205
15	Sensation-NOW: Johns Hopkins University	Baltimore	Maryland	United States	21287
16	RANGER: Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889
17	MATCH: Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
18	RANGER & MATCH: University of Missouri - Columbia	Columbia	Missouri	United States	65212
19	Sensation-NOW: University of Nebraska Medical Center	Omaha	Nebraska	United States	68118
20	RANGER: Multi-Disciplinary Specialists	Rutherford	New Jersey	United States	07070
21	RANGER & MATCH: OrthoCarolina Research Institute, Inc.	Charlotte	North Carolina	United States	28207
22	RANGER & MATCH: Duke University	Durham	North Carolina	United States	27705
23	RANGER: University of Cincinnati	Cincinnati	Ohio	United States	45220
24	Sensation-NOW: University of Cincinnati	Cincinnati	Ohio	United States	45221
25	RANGER: Cleveland Clinic	Cleveland	Ohio	United States	44195
26	RANGER: Ohio State University Medical Center	Columbus	Ohio	United States	43210
27	Sensation-NOW: Ohio State University Medical Center	Columbus	Ohio	United States	43210
28	Sensation-NOW: University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
29	Sensation-NOW: East Cooper Plastic Surgery	Mount Pleasant	South Carolina	United States	29464
30	RANGER & MATCH: Campbell Clinic	Germantown	Tennessee	United States	38138
31	RANGER & MATCH: Vanderbilt University	Nashville	Tennessee	United States	37232
32	Sensation-NOW: Vanderbilt University	Nashville	Tennessee	United States	37232
33	Sensation-NOW: University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
34	RANGER: University of North Texas/John Peter Smith Hospital	Fort Worth	Texas	United States	76104
35	Sensation-NOW: University of North Texas/John Peter Smith Hospital	Fort Worth	Texas	United States	76104
36	Sensation-NOW: Houston-Methodist Central	Houston	Texas	United States	77030
37	Sensation-NOW: Houston-Methodist West/North	Houston	Texas	United States	77094
38	RANGER & MATCH: Texas Tech University HSC	Lubbock	Texas	United States	79430
39	Sensation-NOW: Joshua Lemmon, MD, PLLC	Richardson	Texas	United States	75802
40	RANGER: San Antonio Military Medical Center	San Antonio	Texas	United States	78231
41	Sensation-NOW: PRMA Plastic Surgery	San Antonio	Texas	United States	78240
42	RANGER & MATCH: University of Washington	Seattle	Washington	United States	98195
43	RANGER: University Hospital	Vienna		Austria
44	RANGER: North York General Hospital	Toronto	Ontario	Canada	M2K 1E1
45	RANGER & MATCH: University Hospital Birmingham, England	Edgbaston	Birmingham	United Kingdom	B15 2TH