Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 21, 2018

Primary Completion Date

June 20, 2020

Study Completion Date

December 31, 2020

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).

Trial Locations (4)

Unknown

Grootte Schuur Hospital, Cape Town

Tygerberg Hospital, Cape Town

Inkosi Albert Luthuli Central Hosptial, Durban

Chris Hani Baragwanath Academic Hosptial, Soweto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CoNextions Medical

INDUSTRY