Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

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

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

Conditions
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Tendon Injury - Hand

Intervention / Treatment
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* Procedure: Operative repair of Zone 2 FDP tendon lacerations
* Device: CoNextions TR Implant System
* Device: 4-strand locked cruciate repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Willing and able to provide a signed and dated informed consent form Stated willingness to comply with all study procedures Available for the duration of the study 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 Tendon laceration occurred within the previous 14 days Exclusion Criteria: Pregnant or planning to become pregnant during the follow-up period Autoimmune disorder(s) Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus Lack of proper cutaneous coverage at repair site Concomitant fracture Amputated digit(s) Arthritis of the hand Prior hand trauma with residual impact to function Congenital hand defect Conditions that would affect comparative measurements in the uninjured hand Tendon laceration caused by a crush injury 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 Vascular injuries that require revascularisation procedures Ischemia and/or blood supply compromise Prior or current infections at or near the intended implant site Active sepsis, MRSA, or other conditions that may prevent healing History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE 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 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 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: Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned using a 1:1 randomization scheme to receive either the investigational device or a suture repair for the surgical treatment of their tendon lacerations.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoNextions TR Implant<br>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<br>* Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator<br>Device: CoNextions TR Implant System<br>* The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).<br>|
| Active Comparator: Suture Repair<br>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<br>* Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator<br>Device: 4-strand locked cruciate repair<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FLEXOR TENDON, ZONE 2