Clinical Analysis of a Novel Flexor Tendon Repair Technique
NCT ID: NCT07068880
Last Updated: 2025-07-16
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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RECRUITING
128 participants
OBSERVATIONAL
2024-06-18
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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repair with the CoNextions tendon repair device
No interventions assigned to this group
repair with a "standard of care" repair technique known as the Lew-Omar (LO) technique
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subjects who sustained a Zone 2-5 flexor tendon lacerations
Exclusion Criteria
* Subjects who sustained a Zone 1 flexor tendon injury
* Subjects who have had previous surgical procedures on the injured upper extremity.
* Subjects who have metal allergies
* Ischemia, blood supply compromise, and/or inadequate wound coverage
* Prior or current infections at or near the implant site
* Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period
* Foreign-body sensitivity
* The physical contact of the CoNextions TR Tendon Repair System with metal implants made of anything other than the implant grade of stainless steel, such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals
* Surgical procedures other than for the following indication: digital flexor tendons, digital extensor tendons proximal to the metacarpophalangeal joints (Zones 6-8)
* Tendon size or surgical site access outside of specified range (Tendon Width (3.0-9.0 mm), Tendon Thickness (1.5-4.0 mm), Minimum Surgical Site Access (20 mm \[10mm/side\]) for the CoNextions TR Tendon Repair System
22 Years
88 Years
ALL
No
Sponsors
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Brett Lewellyn
OTHER
Responsible Party
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Brett Lewellyn
Chief Hand & Upper Extremity Surgery
Locations
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Orlando Health
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23.184.09
Identifier Type: -
Identifier Source: org_study_id
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