Flexor Digitorum Longus on the RightDynamicMRINCT03823755
Evaluation of the Mobility of the Digital Flexor Tendons
An observational study of Flexor Digitorum Longus on the Right and Flexor Digitorum Longus on the Left, run by University Hospital, Brest at 3 sites in France.
Trial summary
To study flexor tendon excursion in the hand after surgery by dynamic MRI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Digitorum Longus on the Right, Flexor Digitorum Longus on the Left, Tendon Rupture
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- 31 May 2019to 8 Dec 2020
- Phase
- Observational
- 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
Study population: Adult patient with flexor tendon injury in zone 2 and insufficient functional after surgery with MRI requested for exploration
Who may be able to join
- flexor tendon injury in zone 2
- treatment by surgery
- insufficient functional outcome after surgery
- MRI requested by surgeon
Who cannot join
- pregnancy
- MRI contraindications
- previous surgery on the hand
- rheumatic disorder
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest
Brest, 29200
Clinique Keraudren
Brest, 29200
HIA
Brest, 29240
About this study
Official title: Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.
To study flexor tendon excursion in the hand after surgery by dynamic MRI
Read the detailed description
The study of the movement of the digital flexor tendon operated on MRI could lead to a better understanding of the biomechanics of this tendon after surgery, to objectively assess the repair of the tendon and the recovery of its mobility. The visualization of the aspect and the movement of this operated tendon would make it possible to adapt the rehabilitation for each patient and to prevent the occurrence of complications which limit functional recovery and source of handicap.
The analysis of the imaging in patients evolving would establish useful criteria the surgeon to judge the evolution of the operated tendon.
The first step consists in evaluating the feasibility of the acquisition of dynamic sequences in MRI and the possibility of observing the movement of the flexor tendon operated during the mobilization of the finger, and comparing the biomechanical data obtained with those of the nonoperated tendons and experimental models.
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexor tendon excursion
Imaging of flexor tendon excursion in the hand after surgery during motion with MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start31 May 2019
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Digitorum Longus on the RightStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823755
- Sponsor's protocol ID
- 29BRC18.0214
- Acronym
- DynamicMRI
- Status last verified
- Feb 2023
- First submitted
- 29 Jan 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03823755
- Acronym / sponsor ID
- DynamicMRI / 29BRC18.0214
- Conditions
- Flexor Digitorum Longus on the Right, Flexor Digitorum Longus on the Left, Tendon Rupture, Tendon Injury - Hand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 30 Jan 2019 (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.
To study flexor tendon excursion in the hand after surgery by dynamic MRI
Detailed description
The study of the movement of the digital flexor tendon operated on MRI could lead to a better understanding of the biomechanics of this tendon after surgery, to objectively assess the repair of the tendon and the recovery of its mobility. The visualization of the aspect and the movement of this operated tendon would make it possible to adapt the rehabilitation for each patient and to prevent the occurrence of complications which limit functional recovery and source of handicap.
The analysis of the imaging in patients evolving would establish useful criteria the surgeon to judge the evolution of the operated tendon.
The first step consists in evaluating the feasibility of the acquisition of dynamic sequences in MRI and the possibility of observing the movement of the flexor tendon operated during the mobilization of the finger, and comparing the biomechanical data obtained with those of the nonoperated tendons and experimental models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with flexor tendon injury in zone 2 and insufficient functional after surgery with MRI requested for exploration
Key inclusion criteria (4 listed)
- flexor tendon injury in zone 2
- treatment by surgery
- insufficient functional outcome after surgery
- MRI requested by surgeon
Key exclusion criteria (4 listed)
- pregnancy
- MRI contraindications
- previous surgery on the hand
- rheumatic disorder
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
Flexor tendon excursion
Time frame: 1 year
Imaging of flexor tendon excursion in the hand after surgery during motion with MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flexor Digitorum Longus on the Right and Flexor Digitorum Longus on the Left, run by University Hospital, Brest at 3 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flexor tendon excursion (time frame: 1 year). 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 10 Feb 2023.