RECRUITING

Clinical Analysis of a Novel Flexor Tendon Repair Technique

Description

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
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Related Conditions:

Flexor Tendon Laceration

Study Overview

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Study Details

Study overview

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.

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

Clinical Analysis of a Novel Flexor Tendon Repair Technique

Condition
Flexor Tendon Laceration
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Study subjects aged 22 and older.
  • * Subjects who sustained a Zone 2-5 flexor tendon lacerations
  • * 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

Ages Eligible for Study

22 Years to 88 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brett Lewellyn,

Study Record Dates

2027-07