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Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair

NCT03622372•CoNextions Medical

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age
•2. Willing and able to provide a signed and dated informed consent form
•3. Stated willingness to comply with all study procedures
•4. Available for the duration of the study
•5. Have one or two fully lacerated digital FDP tendon(s), with or without a concomitant injury of the flexor digitorum superficialis, in Zone 2 of the index, middle, ring, or small finger
•6. Tendon laceration occurred within the previous 14 days

Exclusion Criteria

•1. Pregnant or planning to become pregnant during the follow-up period
•2. Autoimmune disorder(s)
•3. Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus
•4. Lack of proper cutaneous coverage at repair site
•5. Concomitant fracture
•6. Amputated digit(s)
•7. Arthritis of the hand
•8. Prior hand trauma with residual impact to function
•9. Congenital hand defect
•10. Conditions that would affect comparative measurements in the uninjured hand
+13 more criteria

Locations (4)

Grootte Schuur Hospital

Cape Town, South Africa

Tygerberg Hospital

Cape Town, South Africa

Inkosi Albert Luthuli Central Hosptial

Durban, South Africa

Chris Hani Baragwanath Academic Hosptial

Soweto, South Africa

Key Dates

Start Date

June 21, 2018

Primary Completion Date

June 20, 2020

Completion Date

December 1, 2020

Last Updated

November 3, 2020

Enrollment

ACTUAL participants

Conditions

Tendon Injury - Hand

Interventions

Operative repair of Zone 2 FDP tendon lacerations

PROCEDURE

CoNextions TR Implant System

DEVICE

4-strand locked cruciate repair

DEVICE

The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery

NCT04787835

Fracture Fixation, InternalMetacarpal Fracture+3 more

View study

COMPLETEDNA

Wide Awake Surgery for Tendon Repair in Hand Trauma

NCT04618107

Tendon Injury - Hand

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Inclusion Criteria

Exclusion Criteria

The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery

Wide Awake Surgery for Tendon Repair in Hand Trauma

Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Flexor Tendon Repair