ClubfootPBVE-MuscleNCT05767762
Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot
A study testing scale Idiopathic Clubfoot in people with Clubfoot, run by Fondation Lenval at 1 site in France.
Trial summary
Clubfoot is an orthopedic congenital malformation of the lower limb of the newborn evaluated by the Dimeglio score. There is a deficit of muscular balance between the agonists and antagonists to the deformity. The Dimeglio score takes into account the muscular activity but only up to one point out of 20. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Clubfoot
- What is being tested?
- scale Idiopathic Clubfoot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2023to Dec 2031
- Phase
- Interventional
- 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 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- idiopathic clubfoot, managed by the functional method, managed before D15 to perform the initial assessment.
Who cannot join
- syndromic clubfoot, management other than functional method, management after D15
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopitaux Pediatriques de Nice Chu-Lenval
Nice, 60200
Grégoire PEUCHEVRIER, 492030323, peuchevrier.g@hpu.lenval.com
Grégoire PEUCHEVRIER
About this study
Official title: Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot
Clubfoot is an orthopedic congenital malformation of the lower limb of the newborn evaluated by the Dimeglio score. There is a deficit of muscular balance between the agonists and antagonists to the deformity. The Dimeglio score takes into account the muscular activity but only up to one point out of 20. This study proposes to use a muscle scale inspired by the Dimeglio score to see if there is a correlation between muscle activity and the risk of tenotomy before 1 year. It will also assess the inter-examiner reproducibility of this scale.
This study is a prospective cohort study with a duration of 8 years to include about 100 feet. Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. Feet will be assessed at an inclusion visit and then at 3-6-12 months.
Read more
The primary endpoint will be the need for Achilles tenotomy before 1 year of age. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis.
The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.
Read the detailed description
Clubfoot is a congenital orthopedic deformity of the lower limb in newborns. It is characterized by a triple deformity of the foot: equinus, supination and adduction of the forefoot. It can be bilateral or unilateral. PBVE can be idiopathic or associated with another etiology such as neurological, rheumatological, etc.
There is a muscular hypoplasia of the muscles antagonistic to the PBVE and an imbalance of force between the agonists and antagonists to the benefit of the deformity. There is also an abnormality of the fibular and posterior tibial nerves.
The aim of the study is the muscular evaluation of the PBVE. The scientific literature is relatively poor on the subject. In the first year of life, if the articular evaluation of the PBVE is very precise, the muscular scoring seems less well taken into account. In the Dimeglio score, the muscular criterion counts for 1 point (against 16 articular points) if it is possible to obtain a muscular contraction of the antagonists. It does not specify which muscles are present nor the active reducibility of the deformity. A scale based on the Dimeglio score has been created to evaluate muscle activity. To fill it out, the practitioner will have to stimulate the muscles antagonistic to the deformity by tactile stimulation.
This will be an 8-year prospective cohort study that will look for a correlation between the muscle deficit and the risk of tenotomy before 1 year as well as the quality of inter-examiner reproduction of the scale. This duration is necessary to obtain a sufficient number of inclusions (100 feet).
Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. At the first consultation, we will perform the Dimeglio score and our muscle activity scale. The Dimeglio and the muscle activity scale will be performed at 3, 6 and 12 months. The population included will need to be sufficient to ensure that all levels of muscle scoring are represented.
The primary endpoint will be the need for Achilles tenotomy before 1 year. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis.
The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.
- Conditions
- Clubfoot
- Being tested
- scale Idiopathic Clubfoot
- Keywords
- Muscle activity, scale, Achilles tenotomy
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scale Idiopathic ClubfootOther
The Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Clubfoot | Experimental | Not described Receives: Other: scale Idiopathic Clubfoot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery
number of patient who need for Achilles tenotomy
Measured: maximum 1 year after inclusion
Secondary outcomes (1)
Inter-examiner reproducibility
measure with statistical study the Inter-examiner reproducibility
Measured: through study completion, an average of 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start26 Apr 2023
- Primary completionMar 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767762
- Sponsor's protocol ID
- 22-HPNCL-09
- Acronym
- PBVE-Muscle
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot
- ClinicalTrials.gov ID
- NCT05767762
- Acronym / sponsor ID
- PBVE-Muscle / 22-HPNCL-09
- Conditions
- Clubfoot
- Keywords
- Muscle activity, scale, Achilles tenotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 14 Mar 2023 (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.
Clubfoot is an orthopedic congenital malformation of the lower limb of the newborn evaluated by the Dimeglio score. There is a deficit of muscular balance between the agonists and antagonists to the deformity. The Dimeglio score takes into account the muscular activity but only up to one point out of 20. This study proposes to use a muscle scale inspired by the Dimeglio score to see if there is a correlation between muscle activity and the risk of tenotomy before 1 year. It will also assess the inter-examiner reproducibility of this scale.
This study is a prospective cohort study with a duration of 8 years to include about 100 feet. Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. Feet will be assessed at an inclusion visit and then at 3-6-12 months.
The primary endpoint will be the need for Achilles tenotomy before 1 year of age. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis.
The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.
Detailed description
Clubfoot is a congenital orthopedic deformity of the lower limb in newborns. It is characterized by a triple deformity of the foot: equinus, supination and adduction of the forefoot. It can be bilateral or unilateral. PBVE can be idiopathic or associated with another etiology such as neurological, rheumatological, etc.
There is a muscular hypoplasia of the muscles antagonistic to the PBVE and an imbalance of force between the agonists and antagonists to the benefit of the deformity. There is also an abnormality of the fibular and posterior tibial nerves.
The aim of the study is the muscular evaluation of the PBVE. The scientific literature is relatively poor on the subject. In the first year of life, if the articular evaluation of the PBVE is very precise, the muscular scoring seems less well taken into account. In the Dimeglio score, the muscular criterion counts for 1 point (against 16 articular points) if it is possible to obtain a muscular contraction of the antagonists. It does not specify which muscles are present nor the active reducibility of the deformity. A scale based on the Dimeglio score has been created to evaluate muscle activity. To fill it out, the practitioner will have to stimulate the muscles antagonistic to the deformity by tactile stimulation.
This will be an 8-year prospective cohort study that will look for a correlation between the muscle deficit and the risk of tenotomy before 1 year as well as the quality of inter-examiner reproduction of the scale. This duration is necessary to obtain a sufficient number of inclusions (100 feet).
Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. At the first consultation, we will perform the Dimeglio score and our muscle activity scale. The Dimeglio and the muscle activity scale will be performed at 3, 6 and 12 months. The population included will need to be sufficient to ensure that all levels of muscle scoring are represented.
The primary endpoint will be the need for Achilles tenotomy before 1 year. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis.
The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Clubfoot | Experimental | Other: scale Idiopathic Clubfoot |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- idiopathic clubfoot, managed by the functional method, managed before D15 to perform the initial assessment.
Key exclusion criteria (1 listed)
- syndromic clubfoot, management other than functional method, management after D15
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 |
|---|---|---|
| scale Idiopathic ClubfootThe Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot | Other | Idiopathic Clubfoot |
Primary outcome
Surgery
Time frame: maximum 1 year after inclusion
number of patient who need for Achilles tenotomy
1 secondary outcome
Inter-examiner reproducibility
Time frame: through study completion, an average of 8 years
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 29 Sep 2023.
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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?
A study testing scale Idiopathic Clubfoot in people with Clubfoot, run by Fondation Lenval 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 1 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: looking for participants now, as of the sponsor's last update on 29 Sep 2023. 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?
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 Grégoire Peuchevrier (492030323 ext. +33, peuchevrier.g@hpu.lenval.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery (time frame: maximum 1 year after inclusion). 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 29 Sep 2023.