An observational study in Flexor Tendon Laceration, sponsored by Brett Lewellyn. Recruiting at 1 site in United States. Open to participants aged 22 Years to 88 Years. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Brett Lewellyn · Observational
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).
Brett Lewellyn is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospital
Exclusion Criteria:
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.
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
Surgical Time
Total surgical time recorded in minutes.
Time frame: From enrollment to end of postoperative follow up at 6-months
Plan to share: No
No publications or documents are linked to this record.
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Brett Lewellyn