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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Tygerberg Hospital
  • Cape Town, South Africa
    • Grootte Schuur Hospital
  • Durban, South Africa
    • Inkosi Albert Luthuli Central Hosptial
  • Soweto, South Africa
    • Chris Hani Baragwanath Academic Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CoNextions TR Implant; Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System	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).
Active Comparator: Suture 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	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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tendon re-rupture	Primary Safety Endpoint	24 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Surgical Site Infection	Presence of infection at the surgical site	24 weeks
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
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
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

Collaborators and Investigators

• Sponsor: CoNextions Medical
• Investigators: Principal Investigator: Michael Solomons, MD, Grootte Schuur Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): June 20, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: FLEXOR TENDON; ZONE 2
• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: TRFDP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes