Actively Recruiting
Clinical Analysis of a Novel Flexor Tendon Repair Technique
Led by Brett Lewellyn · Updated on 2025-07-16
128
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Analysis of a Novel Flexor Tendon Repair Technique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Study subjects aged 22 and older
- Subjects who sustained a Zone 2-5 flexor tendon lacerations
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
Research Team
B
Brett Lewellyn, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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