Peripheral Nerve InjuryPhase 4Nerve-RESTORE℠NCT07657182
Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
A Phase 4 study testing Avance Nerve Graft and Sural nerve autograft in people with Peripheral Nerve Injury and Peripheral Nerve Discontinuity, run by Axogen Corporation at 3 sites in United States.
Trial summary
This is a multicenter, 1:1 randomized, prospective, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Injury, Peripheral Nerve Discontinuity, Mixed Peripheral Nerve Injury
- What is being tested?
- Avance Nerve Graft and Sural nerve autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jun 2026to 5 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study Participant Criteria
- Be ≥ 18 years of age at the time of consent;
- Willing and able to comply with all aspects of the treatment and evaluation schedule over a 24-month duration;
- Provide documented Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to initiation of any study procedures;
- Injury/Repair Criteria for Each Nerve
- Primary or secondary nerve injury repair with sural nerve autograft or Avance Nerve Graft for fully transected reconstruction of the following upper extremity mixed and/or motor nerve(s):
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- Median nerve: proximal nerve stump within 20 cm from the center point of the thenar eminence and distal to the crease of the elbow;
- Anterior interosseous nerve;
- Median nerve recurrent motor branch;
- Radial nerve: proximal nerve stump within 20 cm of the center of the forearm (midpoint between the tip of the olecranon and the styloid process) and distal to the mid-humerus;
- Posterior interosseous nerve.
- Zone of injury of eligible nerve(s) resectable to healthy nerve both distally and proximally and within the anatomical regions of Inclusion Criterion #4;
- In study participants with multiple eligible nerve repairs, repair of all eligible nerves completed with the same study treatment, either Avance Nerve Graft or sural nerve autograft;
- Measured nerve gap(s) following resection > 25 mm;
- Nerve(s) repaired ≤ 120 days post injury;
- Undergo coaptation on both the proximal and distal portion of the nerve gap(s) per the USPI for Avance Nerve Graft and per standard of care for sural nerve autograft; and
- Either treatment method, Avance Nerve Graft or sural nerve autograft, is a viable option for all eligible nerve repair(s) (i.e., volume of injured nerve[s] does not exceed availability of sural nerve autograft for reconstruction, study participants are not treated with a combination of treatment types).
Who cannot join
- Study Participant Criteria
- Currently enrolled in another clinical study that may interfere with treatment, assessment of recovery, or participation in this study;
- Deformities or injuries of the limb, hand, or digits that affect both the primary and secondary assessments for eligible nerve repair(s);
- History of neuropathy of any etiology, diabetic neuropathy or any other known neuropathy including compressive/traumatic neuropathies affecting the target limb;
- History of progressive neurodegenerative or autoimmune disorder affecting peripheral nerve or motor function (e.g., amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease);
- History of chronic ischemic condition of the upper extremity;
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- Expected use of medication during the study that is known to impact nerve regeneration or to cause peripheral neuropathy;
- Undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular systems;
- Participant is unlikely to comply with all study requirements and standard medical care procedures for the duration of the study schedule;
- Injury/Repair Criteria for Each Nerve
- Median nerve repairs where the ulnar nerve has been transected due to injury or repair;
- Repair(s) of a sensory-only proximal nerve stump;
- Incomplete nerve transections;
- Multilevel nerve injury pattern requiring two or more isolated reconstructions along the nerve pathway (for example, reconstruction of median nerve in forearm and recurrent motor branch resulting in repair pattern of graft to native nerve to graft to distal target);
- Inadequate soft tissue coverage or extensive soft tissue injury which will impair recovery assessment;
- Nerve avulsion injuries and nerve traction injuries resulting in rupture of the nerve;
- Replantation/amputation of the limb, hand, or digits involved in both the primary and secondary assessments for eligible nerve repair(s);
- Nerve repairs utilizing either end-to-side or side-to-side coaptation techniques;
- Nerve transfer, tendon transfer, or other concomitant treatment at the time of nerve repair that affects assessment of function of the innervated muscle organ;
- Use of coaptation devices that include metallic components or activated polymers and coaptations completed with fibrin glue only; and
- Injuries with vascular damage resulting in inadequate perfusion despite repair (i.e., both radial and ulnar arteries injured [one injured artery is allowed]).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Missouri- Columbia
Columbia, Missouri, 65121
Bryce Rizanovic, 636-578-9812, brycefletcher@health.missouri.edu
Julia Nuelle, MD
- Recruiting
OrthoIndy
Indianapolis, Indiana, 46260
Melanie Glover, 317-802-2880, mglover@orthoindy.com
Brandon Smetana, MD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Nicolette Clouser, (321) 843-5687, nicolette.clouser@orlandohealth.com
Justin Zumsteg, MD
About this study
Official title: A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
This is a multicenter, 1:1 randomized, prospective, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
Read the detailed description
This is a multicenter, 1:1 randomized, prospective, evaluator blinded, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. The study will assess recovery of motor and sensory function via MRCC score for nerve repairs with Avance Nerve Graft (Study Treatment) and sural nerve autograft (Comparator) through non-inferiority analyses. Participants will be considered enrolled to the study once all screening and eligibility criteria have been met and the participant has been centrally randomized to either Avance Nerve Graft or sural nerve autograft; Inclusion and exclusion criteria are defined at decision points for pre-operative screening eligibility and operative eligibility. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
- Conditions
- Peripheral Nerve Injury, Peripheral Nerve Discontinuity, Mixed Peripheral Nerve Injury, Motor Peripheral Nerve Injury, Upper Extremity Nerve Injury
- Being tested
- Avance Nerve Graft, Sural nerve autograft
- Keywords
- Avance Nerve Graft, Sural Nerve Autograft, Processed Nerve Allograft, Peripheral Nerve Reconstruction, Mixed Nerve Repair, Motor Nerve Repair, MRCC, Nerve Gap, Nerve-RESTORE
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance Nerve GraftBiological
Also called Acellular nerve allograft-arwx
A commercially available, sterile, single-use peripheral nerve scaffold indicated for the treatment of functional deficits, manufactured from decellularized and sterilized extracellular matrix derived from human peripheral nerve tissue.
Sural nerve autograftProcedure or surgery
A patient's own peripheral nerve tissue harvested in a secondary surgical procedure of the lower extremity where a functioning sural nerve is sacrificed for use in the reconstruction of a nerve defect.
| Study group | Role | What they receive |
|---|---|---|
| Avance Nerve Graft | Experimental | Study Treatment: Avance Nerve Graft repairs of mixed or motor nerves (> 25 mm gaps) Receives: Biological: Avance Nerve Graft |
| Sural nerve autograft | Active comparator | Comparator: Sural nerve autograft repairs of mixed or motor nerves (> 25 mm gaps) Receives: Procedure: Sural nerve autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of motor function
Medical Research Council Classification (MRCC) of motor recovery score. This is an ordinal scale from M0-M5, with grade M0 meaning no contraction and M5 meaning full recovery in all muscles.
Measured: Assessed at 24 months
Recovery of sensory function
Medical Research Council Classification (MRCC) of sensory recovery score. This is an ordinal scale from S0-S4, with grade S0 meaning absence of sensibility in the autonomous area and S4 meaning complete recovery (2-point discrimination, 2-6 mm).
Measured: Assessed at 24 months
Secondary outcomes (6)
Meaningful recovery (MR) of motor and sensory function
Medical Research Council Classification (MRCC) of motor recovery score. Meaningful recovery is defined as ≥ M3 MRCC of motor recovery and ≥ S3 MRCC of sensory recovery.
Measured: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
Treatment response (TR) of motor and sensory function
Medical Research Council Classification (MRCC) of motor recovery score. Treatment response is defined as a 1-point increase in MRCC score from post-operative baseline.
Measured: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
Time to MR of motor and sensory function
Time from surgery to meaningful recovery of motor function in all repairs and of sensory function in mixed nerve repairs.
Measured: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
Time to TR of motor and sensory function
Time from surgery to treatment response of motor function in all repairs and of sensory function in mixed nerve repairs.
Measured: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
QuickDASH upper extremity disability score
The QuickDASH questionnaire (including Work and Sports/Performance Art modules if applicable) is a PROM questionnaire to measure physical functions and symptoms in participants with upper limb musculoskeletal disorders and will be used to assess the study participant's functional quality of life (QoL)as it pertains to the affected arm. This 11-item questionnaire addresses arm-specific symptoms and disability during the preceding week and is used to estimate the participant's view of disability. Each item is based on an ordinal scale from 1 to 5, where higher values are worse. QuickDASH scores range from 0 to 100, with a score of 0 indicating no disability and a score of 100 representing the most severe disability.
Measured: Assessed at 24 months
Lower Extremity Functional Scale (LEFS) score
The LEFS is a valid and reliable assessment for documenting function for individuals and groups with injury or disability to the lower extremity. It is based on the World Health Organization's model of disability and handicap and is applicable to a wide variety of participants with lower extremity orthopedic conditions, including participants with a range of disability levels, conditions, diseases, treatments, and ages. Applicable to sural nerve autograft group only. The LEFS consists of 20 questions, with each activity rated from 0 (extremely difficult or unable) to 4 (no difficulty). Scores range from 0 to 80, where higher scores indicate better lower limb function.
Measured: Assessed at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start11 Jun 2026
- Primary completion5 Dec 2030 (estimated)
- Study completion5 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants meeting the inclusion and exclusion criteria are centrally randomized in a 1:1 ratio intra-operatively, following stratification by longest gap length and nerve injured, and all nerve injuries qualifying for study enrollment shall be reconstructed with the same randomly assigned treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Glenn Gaston, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657182
- Sponsor's protocol ID
- ANG-CP-013
- Acronym
- Nerve-RESTORE℠
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
- ClinicalTrials.gov ID
- NCT07657182
- Acronym / sponsor ID
- Nerve-RESTORE℠ / ANG-CP-013
- Conditions
- Peripheral Nerve Injury, Peripheral Nerve Discontinuity, Mixed Peripheral Nerve Injury, Motor Peripheral Nerve Injury, Upper Extremity Nerve Injury
- Keywords
- Avance Nerve Graft, Sural Nerve Autograft, Processed Nerve Allograft, Peripheral Nerve Reconstruction, Mixed Nerve Repair, Motor Nerve Repair, MRCC, Nerve Gap
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 5 Dec 2030 (estimated)
- Study completion
- 5 Dec 2030 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, 1:1 randomized, prospective, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
Detailed description
This is a multicenter, 1:1 randomized, prospective, evaluator blinded, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. The study will assess recovery of motor and sensory function via MRCC score for nerve repairs with Avance Nerve Graft (Study Treatment) and sural nerve autograft (Comparator) through non-inferiority analyses. Participants will be considered enrolled to the study once all screening and eligibility criteria have been met and the participant has been centrally randomized to either Avance Nerve Graft or sural nerve autograft; Inclusion and exclusion criteria are defined at decision points for pre-operative screening eligibility and operative eligibility. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants meeting the inclusion and exclusion criteria are centrally randomized in a 1:1 ratio intra-operatively, following stratification by longest gap length and nerve injured, and all nerve injuries qualifying for study enrollment shall be reconstructed with the same randomly assigned treatment.
| Arm | Type | Receives |
|---|---|---|
| Avance Nerve Graft | Experimental | Biological: Avance Nerve GraftStudy Treatment: Avance Nerve Graft repairs of mixed or motor nerves (> 25 mm gaps) |
| Sural nerve autograft | Active comparator | Procedure: Sural nerve autograftComparator: Sural nerve autograft repairs of mixed or motor nerves (> 25 mm gaps) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Study Participant Criteria
- Be ≥ 18 years of age at the time of consent;
- Willing and able to comply with all aspects of the treatment and evaluation schedule over a 24-month duration;
- Provide documented Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to initiation of any study procedures;
- Injury/Repair Criteria for Each Nerve
Key exclusion criteria (21 listed)
- Study Participant Criteria
- Currently enrolled in another clinical study that may interfere with treatment, assessment of recovery, or participation in this study;
- Deformities or injuries of the limb, hand, or digits that affect both the primary and secondary assessments for eligible nerve repair(s);
- History of neuropathy of any etiology, diabetic neuropathy or any other known neuropathy including compressive/traumatic neuropathies affecting the target limb;
- History of progressive neurodegenerative or autoimmune disorder affecting peripheral nerve or motor function (e.g., amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avance Nerve GraftAlso: Acellular nerve allograft-arwxA commercially available, sterile, single-use peripheral nerve scaffold indicated for the treatment of functional deficits, manufactured from decellularized and sterilized extracellular matrix derived from human peripheral nerve tissue. | Biological | Avance Nerve Graft |
| Sural nerve autograftA patient's own peripheral nerve tissue harvested in a secondary surgical procedure of the lower extremity where a functioning sural nerve is sacrificed for use in the reconstruction of a nerve defect. | Procedure or surgery | Sural nerve autograft |
Primary outcome
Recovery of motor function
Time frame: Assessed at 24 months
Medical Research Council Classification (MRCC) of motor recovery score. This is an ordinal scale from M0-M5, with grade M0 meaning no contraction and M5 meaning full recovery in all muscles.
Recovery of sensory function
Time frame: Assessed at 24 months
Medical Research Council Classification (MRCC) of sensory recovery score. This is an ordinal scale from S0-S4, with grade S0 meaning absence of sensibility in the autonomous area and S4 meaning complete recovery (2-point discrimination, 2-6 mm).
6 secondary outcomes
Meaningful recovery (MR) of motor and sensory function
Time frame: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
Treatment response (TR) of motor and sensory function
Time frame: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
Time to MR of motor and sensory function
Time frame: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
Time to TR of motor and sensory function
Time frame: Assessed at Week 4, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
QuickDASH upper extremity disability score
Time frame: Assessed at 24 months
Lower Extremity Functional Scale (LEFS) score
Time frame: Assessed at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
R. Glenn Gaston, MD principal investigator
OrthoCarolina Research Institute, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avance Nerve Graft and Sural nerve autograft in people with Peripheral Nerve Injury and Peripheral Nerve Discontinuity, run by Axogen Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacy Arnold ((386) 462-6800, clinicalresearch@axogeninc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of motor function (time frame: Assessed at 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.