Flexor Tendon LacerationNCT07068880
Clinical Analysis of a Novel Flexor Tendon Repair Technique
An observational study of Flexor Tendon Laceration, run by Brett Lewellyn at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 88 years
- Conditions the study is for
- Flexor Tendon Laceration
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital
Who may be able to join
- Study subjects aged 22 and older.
- Subjects who sustained a Zone 2-5 flexor tendon lacerations
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Brett Lewellyn, MD, 321-843-5851, Brett.Lewellyn@orlandohealth.com
About this study
Official title: Clinical Analysis of a Novel Flexor Tendon Repair Technique, A Prospective Randomized Trial
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.
Read the 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).
- Conditions
- Flexor Tendon Laceration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| repair with the CoNextions tendon repair device | Not described | |
| repair with a "standard of care" repair technique known as the Lew-Omar (LO) technique | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to end of postoperative follow up at 6-months.
Secondary outcomes (7)
Time to Repair
The units measured will be minutes/seconds for repair
Measured: From enrollment to end of postoperative follow up at 6-months
Visual Analog Pain Scale
Visual number scale to rate pain
Measured: From enrollment to end of postoperative follow up at 6-months
Quick DASH Form
Assessment of symptoms and ability to perform certain activities.
Measured: 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.
Measured: 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
Measured: From enrollment to end of postoperative follow up at 6-months
Range of Motion Assessment
Measured using a goniometer and recorded in degrees.
Measured: From enrollment to end of postoperative follow up at 6-months
Surgical Time
Total surgical time recorded in minutes.
Measured: From enrollment to end of postoperative follow up at 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start18 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon LacerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brett Lewellyn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brett Lewellyn, Orlando Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068880
- Sponsor's protocol ID
- 23.184.09
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of a Novel Flexor Tendon Repair Technique, A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07068880
- Acronym / sponsor ID
- 23.184.09
- Conditions
- Flexor Tendon Laceration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Brett LewellynUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repair with the CoNextions tendon repair device | – | – |
| repair with a "standard of care" repair technique known as the Lew-Omar (LO) technique | – | – |
Who may qualify
- Ages
- 22 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (2 listed)
- Study subjects aged 22 and older.
- Subjects who sustained a Zone 2-5 flexor tendon lacerations
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flexor Tendon Laceration, run by Brett Lewellyn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Lewellyn, MD (321-843-5851, Brett.Lewellyn@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.