Recruiting

CoNextions vs. L-O

Sponsor:

Brett Lewellyn

Code:

NCT07068880

Conditions

Flexor Tendon Laceration

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Flexor Tendon Laceration

Study ID

NCT07068880

Start date

Jun 18, 2024

Status verified date

Jul, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Interventions and Outcome Measures

Arms

repair with the CoNextions tendon repair device

repair with a "standard of care" repair technique known as the Lew-Omar (LO) technique

Primary outcome measure

  • 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. Also to determine if there are similar or different rates of complications and failures [ Time Frame: From enrollment to end of postoperative follow up at 6-months. ]

Central Contacts and Locations

Central contacts

Brett Lewellyn, MD

321-843-5851Brett.Lewellyn@orlandohealth.com

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Brett Lewellyn, MD

321-843-5851Brett.Lewellyn@orlandohealth.com

More Information

Sponsor

Brett Lewellyn

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brett Lewellyn on 2025-07-16.