Clinical Analysis of a Novel Flexor Tendon Repair Technique

Launched by BRETT LEWELLYN · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to repair injured flexor tendons, which are the tendons that help bend your fingers. The researchers want to see how well a new device called the CoNextions tendon repair system works compared to the standard stitching method (called the L-O technique). They will also look at whether one method causes more problems or complications than the other, using both measurements and patient feedback.

Adults aged 22 and older who have recently injured their flexor tendons in certain areas of the hand or fingers (Zones 2 to 5) may be able to join the study. People with injuries in other areas, previous surgeries on the injured hand, metal allergies, infections, or other health issues that affect healing are not eligible. If you join, you can expect to have your tendon repaired using one of the two methods, and the doctors will follow your recovery to see how well the repair works and if there are any complications. The goal is to find the best way to help people regain finger movement after a tendon injury.

Gender

ALL

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 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