Zone 2 Flexor Tendon Repair With CoNextions TR Implant System
NCT ID: NCT03622372
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2018-06-21
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CoNextions TR Implant
Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System
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
CoNextions TR Implant System
The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).
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
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
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).
Interventions
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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
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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CoNextions Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Solomons, MD
Role: PRINCIPAL_INVESTIGATOR
Grootte Schuur Hospital
Locations
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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
Countries
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Other Identifiers
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TRFDP1
Identifier Type: -
Identifier Source: org_study_id