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

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

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.