Flexor Tendon InjuryFLEXORNCT02461680
Treatment for Partial Lesions of the Fingers Flexor Tendons : Tangential Resection or Direct Suture
A study testing tangential resection and suture in people with Flexor Tendon Injury and Lesions Of The Fingers Flexor Tendons, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Tendon Injury, Lesions Of The Fingers Flexor Tendons
- What is being tested?
- tangential resection and suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- wound dating less than 48 hours
- partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2
- tendinous injuries on a single finger
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture
Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications.
The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)
- Being tested
- tangential resection, suture
- Keywords
- partial section of the flexor tendons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tangential resectionProcedure or surgery
the tendon's injury is treated with a tangential resection performed with a surgical blade N°11 The shape of the tangential resection was adapted such that the cross-section disappered
sutureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Tangential resection | Experimental | the tendon's injury is treated with a tangential resection Receives: Procedure: tangential resection |
| Suture | Active comparator | The tendon's injury is sutured Receives: Procedure: suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total active motion Grasp
Total active motion is the addition of angles in flexion of IPP, IPD and MCP joints of a finger in active mobility
Measured: third month,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sybille FACCA, MD, Principal investigator, CHU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461680
- Sponsor's protocol ID
- 6021
- Acronym
- FLEXOR
- Status last verified
- Aug 2019
- First submitted
- 27 May 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture
- ClinicalTrials.gov ID
- NCT02461680
- Acronym / sponsor ID
- FLEXOR / 6021
- Keywords
- partial section of the flexor tendons
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 3 Jun 2015 (estimated)
- 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.
Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications.
The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tangential resection | Experimental | Procedure: tangential resectionthe tendon's injury is treated with a tangential resection |
| Suture | Active comparator | Procedure: sutureThe tendon's injury is sutured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- wound dating less than 48 hours
- partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2
- tendinous injuries on a single finger
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tangential resectionthe tendon's injury is treated with a tangential resection performed with a surgical blade N°11 The shape of the tangential resection was adapted such that the cross-section disappered | Procedure or surgery | Tangential resection |
| suture | Procedure or surgery | Suture |
Primary outcome
Total active motion Grasp
Time frame: third month,
Total active motion is the addition of angles in flexion of IPP, IPD and MCP joints of a finger in active mobility
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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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. This study is not recruiting at the moment.
Sybille FACCA, MD principal investigator
CHU Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tangential resection and suture in people with Flexor Tendon Injury and Lesions Of The Fingers Flexor Tendons, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Aug 2019. 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 France. 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?
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total active motion Grasp (time frame: third month,). 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 21 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.