CoNextions device versus L-O suture repair for flexor tendon lacerations

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

This trial will test whether the CoNextions tendon repair device or the standard L-O suture repair leads to fewer ruptures and complications in adults aged 22 and older with Zone 2-5 flexor tendon lacerations.

Quick facts

• Study type: Observational
• Enrollment: 128 (estimated)
• Ages: 22 Years to 88 Years
• Sex: All
• Sponsor: Orlando Health, Inc. (other)
• Locations: 1 site (Orlando, Florida)
• Trial ID: NCT07068880 on ClinicalTrials.gov

What this trial studies

This observational comparison follows adults with Zone 2-5 flexor tendon lacerations who receive either the CoNextions tendon repair device or the standard L-O suture repair. Investigators will track tendon failures, ruptures, and other complications during surgery and at 2-week, 6-week, 3-month, and 6-month follow-ups. The study collects both objective measures (rupture/failure rates) and patient-reported outcomes to characterize functional recovery. Enrollment excludes patients with prior surgery on the injured limb, metal allergies, active infection, inadequate blood supply, or other contraindications.

Who should consider this trial

Good fit: Adults aged 22 and older with acute Zone 2-5 flexor tendon lacerations who have not had prior surgery on the injured extremity and have no contraindications like metal allergy or active infection.

Not a fit: Patients under 22, those with Zone 1 injuries, prior surgery on the injured limb, active infection, inadequate blood supply, metal allergies, or incompatible metal implants would not be eligible and are unlikely to benefit.

Why it matters

Potential benefit: If successful, the CoNextions device could reduce tendon rupture rates and lower the need for repeat surgery or prolonged immobilization.

How similar studies have performed: Standard suture repairs like the L-O technique are well established, while the CoNextions device represents a relatively new approach with limited published clinical outcome data.

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

Where this trial is running

Orlando, Florida

• Orlando Health — Orlando, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Brett Lewellyn, MD

Conditions: Flexor Tendon Laceration