Clinical trial NCT03622372: Zone 2 Flexor Tendon Repair With CoNextions TR Implant System
Official title: Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Tendon Injury - Hand
Keywords: FLEXOR TENDON
ZONE 2
Lead sponsor: CoNextions Medical
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of tendon re-rupture
timeFrame: 24 weeks
measure: Mobility of the affected digits using Strickland's Revised Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)
timeFrame: 24 weeks
measure: Surgical Site Infection
timeFrame: 24 weeks
measure: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Grootte Schuur Hospital
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Durban
country: South Africa
facility: Inkosi Albert Luthuli Central Hosptial
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Academic Hosptial
Study officials:
affiliation: Grootte Schuur Hospital
name: Michael Solomons, MD
role: PRINCIPAL_INVESTIGATOR
References: