Flexor Tendon Laceration
Conditions
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.
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).
Interventions
None listed
Sponsors
Brett Lewellyn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 88 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | From enrollment to end of postoperative follow up at 6-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale | From enrollment to end of postoperative follow up at 6-months | Visual number scale to rate pain |
| Quick DASH Form | From enrollment to end of postoperative follow up at 6-months | Assessment of symptoms and ability to perform certain activities. |
| Patient Satisfaction Questionnaire | From enrollment to end of postoperative follow up at 6-months | Assessment of perceptions of technical quality, interpersonal manner, communication, financial aspects, time spent with the doctor, accessibility, and convenience, as well as overall general satisfaction. |
| Time to Repair | From enrollment to end of postoperative follow up at 6-months | The units measured will be minutes/seconds for repair |
| Range of Motion Assessment | From enrollment to end of postoperative follow up at 6-months | Measured using a goniometer and recorded in degrees. |
| Surgical Time | From enrollment to end of postoperative follow up at 6-months | Total surgical time recorded in minutes. |
| Grip/Strength Assessment | From enrollment to end of postoperative follow up at 6-months | Measured using a hand-held dynamometer in units of pounds/kilograms |
Countries
United States
Contacts
Primary ContactBrett Lewellyn, MD
Outcome results
None listed