Clinical Analysis of a Novel Flexor Tendon Repair Technique

Brett Lewellyn

Status: Enrolling

Conditions: Flexor Tendon Laceration

Study type: Observational

Funder types: Other

Identifiers

NCT07068880

23.184.09

Details and patient eligibility

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.

Full 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).

Enrollment: 128 estimated patients

Sex: All

Ages: 22 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

128 participants in 2 patient groups

repair with the CoNextions tendon repair device

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