Trials / Active Not Recruiting
Active Not RecruitingNCT03622372
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- CoNextions Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2018-06-21
- Primary completion
- 2020-06-20
- Completion
- 2020-12-01
- First posted
- 2018-08-09
- Last updated
- 2020-11-03
Locations
4 sites across 1 country: South Africa
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03622372. Inclusion in this directory is not an endorsement.