RECRUITING

Clinical Analysis of a Novel Flexor Tendon Repair Technique

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-18
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07068880

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.

Ages Eligible for Study:22 Years to 88 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study subjects aged 22 and older.
  2. * Subjects who sustained a Zone 2-5 flexor tendon lacerations
  1. * Subjects under the age of 22 at the time of consent
  2. * Subjects who sustained a Zone 1 flexor tendon injury
  3. * Subjects who have had previous surgical procedures on the injured upper extremity.
  4. * Subjects who have metal allergies
  5. * Ischemia, blood supply compromise, and/or inadequate wound coverage
  6. * Prior or current infections at or near the implant site
  7. * Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period
  8. * Foreign-body sensitivity
  9. * 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
  10. * Surgical procedures other than for the following indication: digital flexor tendons, digital extensor tendons proximal to the metacarpophalangeal joints (Zones 6-8)
  11. * 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

Contacts and Locations

Study Contact

Brett Lewellyn, MD
CONTACT
321-843-5851
Brett.Lewellyn@orlandohealth.com

Study Locations (Sites)

Orlando Health
Orlando, Florida, 32806
United States

Collaborators and Investigators

Sponsor: Brett Lewellyn

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-06-18
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Flexor Tendon Laceration