Completed

RECONA 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

What is being tested

Processed Nerve Allograft (human)

+ Collagen Nerve Cuff

BiologicalDevice

Who is being recruted

From 18 to 65 Years

+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2015

See protocol details

Summary

Principal SponsorAxogen Corporation

Last updated: July 12, 2023

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2015

Actual date on which the first participant was enrolled.

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.

NCT01809002

Principal SponsorAxogen Corporation

Last updated: July 12, 2023

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

Peripheral Nerve Injury

2 exclusion criteria prevent from participating

Allergic to Bovine products such as Bovine Collagen Nerve Cuff

Peripheral Neuropathy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Processed Nerve Allograft

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

University California, Davis

Sacramento, United StatesOpen University California, Davis in Google Maps

University of Florida

Gainesville, United States

University of Miami

Miami, United States

Florida Orthopaedic Institute

Tampa, United States

Completed21 Study Centers