Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

CoNextions Medical

Status and phase: Unknown; Phase 3

Conditions: Tendon Injury - Hand

Treatments: Device: 4-strand locked cruciate repair; Device: CoNextions TR Implant System; Procedure: Operative repair of Zone 2 FDP tendon lacerations

Study type: Interventional

Funder types: Industry

Identifiers

NCT03622372

TRFDP1

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

11. Tendon laceration caused by a crush injury

12. Prior sensory impairment in digits of either hand. Note: Participants with nerve injuries associated with the trauma causing the current flexor tendon injury are eligible for enrollment

13. Vascular injuries that require revascularisation procedures

14. Ischemia and/or blood supply compromise

15. Prior or current infections at or near the intended implant site

16. Active sepsis, MRSA, or other conditions that may prevent healing

17. History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE

18. Implantation of CoNextionsTR Implant would result in physical contact with other metal implants made of material other than implant grade stainless steel such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals

19. Any condition(s) which, in the opinion of the investigator, may impact the participant's ability to properly follow-up or otherwise be at-risk for following protocol instructions

20. Currently participating in another clinical/device trial

    The following criteria, determined during the surgical procedure, will also cause an individual to be excluded from the study:

21. Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site

22. Injured tendon is outside of the width range (3.0-7.0 mm) and thickness range (1.5-4.0 mm) specified for the CoNextionsTR Implant System.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

CoNextions TR Implant

Experimental group

Description:

Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System

Treatment:

Procedure: Operative repair of Zone 2 FDP tendon lacerations

Device: CoNextions TR Implant System

Suture Repair

Active Comparator group

Description:

Operative repair of Zone 2 FDP tendon lacerations will be performed using a 4-strand locked cruciate repair utilizing either 3.0 or 4.0 prolene suture

Treatment:

Procedure: Operative repair of Zone 2 FDP tendon lacerations

Device: 4-strand locked cruciate repair