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Recruiting NCT07068880

Clinical Analysis of a Novel Flexor Tendon Repair Technique

— Observational Flexor Tendon Laceration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Flexor Tendon Laceration. Basic parameters: 22 years — 88 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed 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).

Primary outcome measures

  • 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.]
Secondary outcome measures (7)
  • Time to Repair [Time frame: From enrollment to end of postoperative follow up at 6-months]
  • Visual Analog Pain Scale [Time frame: From enrollment to end of postoperative follow up at 6-months]
  • Quick DASH Form [Time frame: From enrollment to end of postoperative follow up at 6-months]
  • Patient Satisfaction Questionnaire [Time frame: From enrollment to end of postoperative follow up at 6-months]
  • Grip/Strength Assessment [Time frame: From enrollment to end of postoperative follow up at 6-months]
  • Range of Motion Assessment [Time frame: From enrollment to end of postoperative follow up at 6-months]
  • Surgical Time [Time frame: From enrollment to end of postoperative follow up at 6-months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Orlando Health — Orlando

Identifiers

NCT: NCT07068880 · 23.184.09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗