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Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

NCT03622372 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-11-03

No results posted yet for this study

Summary

Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.

Conditions

  • Tendon Injury - Hand

Interventions

PROCEDURE

Operative repair of Zone 2 FDP tendon lacerations

Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator

DEVICE

CoNextions TR Implant System

The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).

DEVICE

4-strand locked cruciate repair

A 4-strand locked cruciate repair utilizing either 3.0 or 4.0 prolene suture will be used to repair Zone 2 FDP tendon laceration(s).

Sponsors & Collaborators

  • CoNextions Medical

    lead INDUSTRY

Principal Investigators

  • Michael Solomons, MD · Grootte Schuur Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2020-06-20
Completion
2020-12-31
FDA Device
Yes

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622372 on ClinicalTrials.gov