Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (RECON)
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ClinicalTrials.gov Identifier: NCT01809002 |
Recruitment Status :
Active, not recruiting
First Posted : March 12, 2013
Last Update Posted : August 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Nerve Discontinuities | Biological: Processed Nerve Allograft (human) Device: Collagen Nerve Cuff | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 2015 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | November 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Processed Nerve Allograft
Processed Nerve Allograft
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Biological: Processed Nerve Allograft (human) |
Active Comparator: Collagen Nerve Cuff |
Device: Collagen Nerve Cuff
Bovine collagen based nerve cuff |
- Recovery of Static Two Point Discrimination Assessed by Discriminator (in mm) [ Time Frame: 12 month ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Peripheral Nerve Injury
Exclusion Criteria:
- Peripheral Neuropathy
- Allergic to Bovine products such as Bovine Collagen Nerve Cuff

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): NCT01809002

Principal Investigator: | Jonathan E Isaacs, MD | Virginia Commonwealth University Medical Center | |
Principal Investigator: | L. Scott Levin, MD FACS | University of Pennsylvania |
Responsible Party: | Axogen Corporation |
ClinicalTrials.gov Identifier: | NCT01809002 |
Other Study ID Numbers: |
ANG-CP-007 |
First Posted: | March 12, 2013 Key Record Dates |
Last Update Posted: | August 19, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |