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Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Phase 3Active Not RecruitingNCT03622372
CoNextions Medical90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

90

Conditions

Tendon Injury - Hand

Interventions

Operative repair of Zone 2 FDP tendon lacerationsPROCEDURE

Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator

CoNextions TR Implant SystemDEVICE

The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).

4-strand locked cruciate repairDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years
Medical Language ↔ Plain English
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.

Locations (4)

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, South Africa

Outcomes

Primary Outcomes

Rate of tendon re-rupture

Primary Safety Endpoint

Time frame: 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%).

Time frame: 24 weeks

Secondary Outcomes

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).

Time frame: 24 weeks

Surgical Site Infection

Presence of infection at the surgical site

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 24 weeks

Data from ClinicalTrials.gov

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