Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Tendon Injury - Hand Clinical Trial

Official title:

Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03622372
• Other study ID #: TRFDP1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 21, 2018
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: CoNextions Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tendon Injuries
• Tendon Injury - Hand

Intervention

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).
• 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).

Locations

Country	Name	City	State
South Africa	Grootte Schuur Hospital	Cape Town
South Africa	Tygerberg Hospital	Cape Town
South Africa	Inkosi Albert Luthuli Central Hosptial	Durban
South Africa	Chris Hani Baragwanath Academic Hosptial	Soweto

Sponsors (1)

Lead Sponsor	Collaborator
CoNextions Medical

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of tendon re-rupture	Primary Safety Endpoint	24 weeks
Primary	Mobility of the affected digits using Strickland's Revised Score	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%).	24 weeks
Secondary	Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)	Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain).	24 weeks
Secondary	Surgical Site Infection	Presence of infection at the surgical site	24 weeks
Secondary	Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire	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.	24 weeks
Secondary	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	The average of three grip strength values taken in succession (kilograms).	24 weeks
Secondary	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	The average of three tip pinch strength values taken in succession (kilograms).	24 weeks