Orthopedic Equine Varus DeformitytalobotNCT02790346
Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot
A study testing arthrodesis talonavicular and tendon gestures in people with Orthopedic Equine Varus Deformity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Orthopedic Equine Varus Deformity
- What is being tested?
- arthrodesis talonavicular and tendon gestures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 27 Jun 2023
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months
- Orthopedic equine-varus deformity of the foot and ankle requiring surgery
- Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability
Who cannot join
- History of foot surgery the side to be operated
- Significant deformation set foot and ankle (requiring treatment with triple arthrodesis)
- Bilateral surgery
- Progressive neurological disease
- Dystonic movements or movement disorders
- Realization of a botulinum toxin injection in the 6 months preceding gesture
- Important cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study
This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.
- Conditions
- Orthopedic Equine Varus Deformity
- Being tested
- arthrodesis talonavicular, tendon gestures
- Keywords
- hemiparesis, deformity of the foot and ankle
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthrodesis talonavicularProcedure or surgery
tendon gesturesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| arthrodesis talonavicular | Experimental | arthrodesis talonavicular in addition to tendon gestures Receives: Procedure: arthrodesis talonavicular; Procedure: tendon gestures |
| tendon gestures | Active comparator | tendon gestures only Receives: Procedure: tendon gestures |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed at one year
Measured: 12 months after surgery intervention
Secondary outcomes (1)
walking speed at 3 and 6 months
Measured: 3 months and 6 months after surgery intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startDec 2015
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Equine Varus DeformityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790346
- Sponsor's protocol ID
- 9547
- Acronym
- talobot
- Status last verified
- Mar 2024
- First submitted
- 17 May 2016
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study
- ClinicalTrials.gov ID
- NCT02790346
- Acronym / sponsor ID
- talobot / 9547
- Conditions
- Orthopedic Equine Varus Deformity
- Keywords
- hemiparesis, deformity of the foot and ankle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 3 Jun 2016 (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.
This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arthrodesis talonavicular | Experimental | Procedure: arthrodesis talonavicular, Procedure: tendon gesturesarthrodesis talonavicular in addition to tendon gestures |
| tendon gestures | Active comparator | Procedure: tendon gesturestendon gestures only |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months
- Orthopedic equine-varus deformity of the foot and ankle requiring surgery
- Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability
Key exclusion criteria (7 listed)
- History of foot surgery the side to be operated
- Significant deformation set foot and ankle (requiring treatment with triple arthrodesis)
- Bilateral surgery
- Progressive neurological disease
- Dystonic movements or movement disorders
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 |
|---|---|---|
| arthrodesis talonavicular | Procedure or surgery | arthrodesis talonavicular |
| tendon gestures | Procedure or surgery | arthrodesis talonavicular, tendon gestures |
Primary outcome
walking speed at one year
Time frame: 12 months after surgery intervention
1 secondary outcome
walking speed at 3 and 6 months
Time frame: 3 months and 6 months after surgery intervention
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 22 Mar 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthrodesis talonavicular and tendon gestures in people with Orthopedic Equine Varus Deformity, run by University Hospital, Montpellier 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 7 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 22 Mar 2024. 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 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?
walking speed at one year (time frame: 12 months after surgery intervention). 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 22 Mar 2024.