Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Phase 3

• Conditions: Tendon Injury - Hand
• Interventions: Procedure: Operative repair of Zone 2 FDP tendon lacerations; Device: CoNextions TR Implant System; Device: 4-strand locked cruciate repair

• Registration Number: NCT03622372
• Lead Sponsor: CoNextions Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-21
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Primary Completion: 2020-06-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-01
• Last Update Posted: 2020-11-03
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CoNextions TR Implant	CoNextions TR Implant System	Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System
CoNextions TR Implant	Operative repair of Zone 2 FDP tendon lacerations	Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System
Suture Repair	Operative repair of Zone 2 FDP tendon lacerations	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
Suture Repair	4-strand locked cruciate repair	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

Primary Outcome Measures

Name	Time	Method
Rate of tendon re-rupture	24 weeks	Primary Safety Endpoint
Mobility of the affected digits using Strickland's Revised Score	24 weeks	Primary Effectiveness Endpoint-Strickland's Revised Score provides a descriptive measure of the mobility of digits. Range of motion measurements taken on the studied digits are used to generate a score on a 0 (least mobile) to 100 (most mobile) with outcomes being classified as: excellent (75-100%), good (50-784%), fair (25-49%), or poor (\<25%).

Secondary Outcome Measures

Name	Time	Method
Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)	24 weeks	Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain).
Surgical Site Infection	24 weeks	Presence of infection at the surgical site
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire	24 weeks	DASH is a patient-reported questionnaire consisting of 30 questions designed to evaluate a patients ability to perform certain upper extremity activities. The patients answers are used to calculate a score from 1 (most disabled) to 100 (least disabled). DASH is validated to be able to detect small and large changes over time, most notably before and after surgical interventions in the upper extremity.
Grip Strength measured using a dynamometer with values for the affected hand being calculated as a percentage of the grip strength of the unaffected hand	24 weeks	The average of three grip strength values taken in succession (kilograms).
Tip pinch strength measured with a pinch gauge with values for the affected fingers calculated as a percentage of the tip pinch strength for corresponding fingers on the unaffected hand	24 weeks	The average of three tip pinch strength values taken in succession (kilograms).

Trial Locations

Locations (4)

Tygerberg Hospital; 🇿🇦 Cape Town, South Africa

Inkosi Albert Luthuli Central Hosptial; 🇿🇦 Durban, South Africa

Chris Hani Baragwanath Academic Hosptial; 🇿🇦 Soweto, South Africa

Grootte Schuur Hospital; 🇿🇦 Cape Town, South Africa