Peripheral Nerve DiscontinuitiesPhase 3RECONNCT01809002
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
A Phase 3 study testing Processed Nerve Allograft (human) and Collagen Nerve Cuff in people with Peripheral Nerve Discontinuities, run by Axogen Corporation at 21 sites in United States.
Trial summary
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Discontinuities
- What is being tested?
- Processed Nerve Allograft (human) and Collagen Nerve Cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2015to 30 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral Nerve Injury
Who cannot join
- Peripheral Neuropathy
- Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Curtis National Hand Center
Baltimore, Maryland, 21218
Medical University of South Carolina
Charleston, South Carolina, 29425
Univeristy of Virginia
Charlottesville, Virginia, 22908
Duke University
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32611
Spectrum Health
Grand Rapids, Michigan, 49503
Penn State Universtiy
Hershey, Pennsylvania, 16801
Marshall Orthopaedics
Huntington, West Virginia, 25701
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Hand Surgery Specialists of Nevada
Las Vegas, Nevada, 89148
University of Kentucky
Lexington, Kentucky, 40506
University of Miami
Miami, Florida, 33146
Hennepin Healthcare
Minneapolis, Minnesota, 55415
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rothman Institute
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23228
University of Rochester Medical Center
Rochester, New York, 14627
University California, Davis
Sacramento, California, 95817
Florida Orthopaedic Institute
Tampa, Florida, 33609
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.
- Conditions
- Peripheral Nerve Discontinuities
- Being tested
- Processed Nerve Allograft (human), Collagen Nerve Cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed Nerve Allograft (human)Biological
Collagen Nerve CuffDevice
Bovine collagen based nerve cuff
| Study group | Role | What they receive |
|---|---|---|
| Processed Nerve Allograft | Experimental | Processed Nerve Allograft Receives: Biological: Processed Nerve Allograft (human) |
| Collagen Nerve Cuff | Active comparator | Not described Receives: Device: Collagen Nerve Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
Measured: Month 12
Static Two-Point Discrimination (Data As-reported)
s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
Measured: Up to Month 12
Secondary outcomes (5)
Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)
This is the percentage of subjects who achieved sensibility as defined by s2PD 2mm-15mm at Month 12. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). This analysis was completed on the Intent-to-Treat population, defined as all subjects who were randomized.
Measured: Month 12
Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)
This is the ratio of sensibility at Month 12 relative to sensibility at baseline for which the contralateral control value at Month 12 was used, expressed as a percentage. Pre-injury baseline was defined as s2PD at Month 12 in the contralateral digit associated with the target digit. Percent recovery to Pre-Injury Baseline was defined as: change from Pre-Injury Baseline (Contralateral control value) divided by the Pre-Injury Baseline Value *100. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). This analysis was completed on the Intent-to-Treat population, defined as all subjects who were randomized.
Measured: Month 12
Time to Recovery of s2PD (Data As-reported)
Time to recovery of s2PD was defined as the number of months from Operative day to the return of sensory function (defined as Medical Research Council sensory function score of S3+ or greater) at Month 3, Month 6, Month 9, or Month 12. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. S4 is s2PD of 2-6mm and S3+ is s2PD of 7-15mm. Those without S3+ and absent values were considered not recovered. This is the Intent To Treat population which includes all subjects that were randomized. Any subject with a value of s2PD of absent was considered not recovered and was therefore not included in this analysis.
Measured: Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op)
Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)
MRC classification score is a functional recovery classification. For nerves with sensory targets, outcomes resulting from static two-point discrimination and Semmes-Weinstein Monofilament pressure threshold testing are used to determine the classification score. Sensibility testing for the target repair was performed by a blinded assessor using a standardized discriminator tool and Semmes-Weinstein monofilaments. Upper bound response for static two-point discrimination was 15mm. This is the Intent To Treat population which includes all subjects that were randomized and have a reported value at Month 12. Scale range: Minimum S0 = 0 (no sensibility), S1=1, S2=2, S3=3, S3+=4, maximum S4 = 5 (normative levels of sensibility). Higher values represented better outcomes.
Measured: Month 12
Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicated their current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data were recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable". This is the Intent To Treat population which includes all subjects that were randomized. The analysis was performed using a standard statistical analysis on Month 12 data. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startJun 2015
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve DiscontinuitiesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan E Isaacs, MD, Principal investigator, Virginia Commonwealth University Medical CenterL. Scott Levin, MD FACS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809002
- Sponsor's protocol ID
- ANG-CP-007
- Acronym
- RECON
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2013
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isaacs J, Eswaran S, Ilyas A, Means KR, Levin LS. Digital Nerve Repair With Flexor Tendon Injury: Conduits are Less Effective. Hand (N Y). 2025 Dec 30:15589447251406917. doi: 10.1177/15589447251406917. Online ahead of print.
PubMed 41472406
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities
- ClinicalTrials.gov ID
- NCT01809002
- Acronym / sponsor ID
- RECON / ANG-CP-007
- Conditions
- Peripheral Nerve Discontinuities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Posted 12 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Processed Nerve Allograft | Experimental | Biological: Processed Nerve Allograft (human)Processed Nerve Allograft |
| Collagen Nerve Cuff | Active comparator | Device: Collagen Nerve Cuff |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peripheral Nerve Injury
Key exclusion criteria (2 listed)
- Peripheral Neuropathy
- Allergic to Bovine products such as Bovine Collagen Nerve Cuff
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 |
|---|---|---|
| Processed Nerve Allograft (human) | Biological | Processed Nerve Allograft |
| Collagen Nerve CuffBovine collagen based nerve cuff | Device | Collagen Nerve Cuff |
Primary outcome
Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
Time frame: Month 12
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
Static Two-Point Discrimination (Data As-reported)
Time frame: Up to Month 12
s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
5 secondary outcomes
Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)
Time frame: Month 12
Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)
Time frame: Month 12
Time to Recovery of s2PD (Data As-reported)
Time frame: Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op)
Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)
Time frame: Month 12
Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41472406Isaacs J, Eswaran S, Ilyas A, Means KR, Levin LS. Digital Nerve Repair With Flexor Tendon Injury: Conduits are Less Effective. Hand (N Y). 2025 Dec 30:15589447251406917. doi: 10.1177/15589447251406917. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Peripheral Nerve Discontinuities
Recruiting
Effect of Nerve Stimulation on Sciatic Nerve Injury Pediatric Patients
Leg Pain, Peripheral Nerve Discontinuities
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. This study is not recruiting at the moment.
Jonathan E Isaacs, MD principal investigator
Virginia Commonwealth University Medical Center
L. Scott Levin, MD FACS principal investigator
University of Pennsylvania
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Processed Nerve Allograft (human) and Collagen Nerve Cuff in people with Peripheral Nerve Discontinuities, run by Axogen Corporation at 21 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach) (time frame: Month 12). 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?
On the ClinicalTrials.gov record for NCT01809002, which also lists 1 linked publication.
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 12 Jul 2023.