NCT07068880 · Brett Lewellyn
Clinical Analysis of a Novel Flexor Tendon Repair Technique
What this study is about
The purpose of the research study is to determine the effectiveness and efficiency of two tendon repair techniques: the CoNextions tendon repair device vs a the usual treatment, 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.
View original scientific 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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Orlando, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2025 · Source of record for eligibility and locations