NCT07068880

Clinical Analysis of a Novel Flexor Tendon Repair Technique

Clinical Analysis of a Novel Flexor Tendon Repair Technique, A Prospective Randomized Trial

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 128 (estimated)
• Sponsor: Brett Lewellyn · Academic / Other
• Sex: All
• Age: 22 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. The investigators will determine if there are similar or different rates of complications and failures (both intraoperatively and at 2-week, 6-week, 3-month, and 6-month post-operative intervals).

Conditions

• Flexor Tendon Laceration

Timeline

• Start date: 2024-06-18
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States