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.
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).
Study Type
OBSERVATIONAL
Enrollment
128
Orlando Health
Orlando, Florida, United States
RECRUITINGTo 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.
Time to Repair
The units measured will be minutes/seconds for repair
Time frame: From enrollment to end of postoperative follow up at 6-months
Visual Analog Pain Scale
Visual number scale to rate pain
Time frame: From enrollment to end of postoperative follow up at 6-months
Quick DASH Form
Assessment of symptoms and ability to perform certain activities.
Time frame: From enrollment to end of postoperative follow up at 6-months
Patient Satisfaction Questionnaire
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 frame: From enrollment to end of postoperative follow up at 6-months
Grip/Strength Assessment
Measured using a hand-held dynamometer in units of pounds/kilograms
Time frame: From enrollment to end of postoperative follow up at 6-months
Range of Motion Assessment
Measured using a goniometer and recorded in degrees.
Time frame: From enrollment to end of postoperative follow up at 6-months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Surgical Time
Total surgical time recorded in minutes.
Time frame: From enrollment to end of postoperative follow up at 6-months