Clinical Analysis of a Novel Flexor Tendon Repair Technique
Recruiting
Observational Study
Flexor Tendon Laceration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
22 – 88
Sex
Any
Study type
Observational
Participants needed
128 (estimated)
Sponsor
Brett Lewellyn · Other
Who this trial is looking for
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The purpose of the research study is to determine the efficacy and efficiency of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care, L-O (Lew-Omar), suture repair technique. The investigators will also determine if there are similar or different rates of complications and failures via both objective and subjective measures.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Study subjects aged 22 and older.
* Subjects who sustained a Zone 2-5 flexor tendon lacerations
Exclusion Criteria:
* Subjects under the age of 22 at the time of consent
* Subjects who sustained a Zone 1 flexor tendon injury
* Subjects who have had previous surgical procedur…
Inclusion Criteria:
* Study subjects aged 22 and older.
* Subjects who sustained a Zone 2-5 flexor tendon lacerations
Exclusion Criteria:
* Subjects under the age of 22 at the time of consent
* 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
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