Foot DeformitiesNCT04312828
Assessment of Orthopedic Care of the Z-shaped Foot in Infant
An observational study of Foot Deformities, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Foot Deformities
- What is being tested?
- Orthopedic management of the Z-foot
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2020to 23 Jun 2022
- 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 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who suffered from a congenital idiopathic Z-foot deformation, aged 6 months to 2 years at the time of orthopedic treatment.
Who may be able to join
- Child having presented a congenital idiopathic malformation uni- or bilateral of foot in Z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump;
- Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion;
- Child aged 6 months to 2 years at the start of care;
- Authorization of the parents or the legal representative of the child to collect personal information about their child.
Who cannot join
- Child having presented a secondary Z foot;
- History of foot surgery;
- Lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care;
- Inability of the parents or the child's legal representative to understand the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Orthopedic Care of the Z-shaped Foot in Children From 6 Months to 2 Years Old
Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.
Read the detailed description
The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.
Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.
- Conditions
- Foot Deformities
- Being tested
- Orthopedic management of the Z-foot
- Medical subject headings
- Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic management of the Z-footProcedure or surgery
Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention
What is being measured
The primary outcome is the main question the study is designed to answer.
The main criterion of the study is the success rate of orthopedic management of the Z-foot.
Success is a composite criterion, measured at the last follow-up, defined by:
- Outer edge of the straight foot; AND
- Absence of dorsolateral hump OR possibility of putting on shoes without difficulty AND
- Absence of recurrence of the malformation OR resumption of surgery OR resumption of orthopedic treatment.
Measured: 9 months
Secondary outcomes (3)
Moderate success rate of the procedure
Defined by an external edge of the foot that is not rectilinear but the possibility of normal footwear, at the greatest distance (relative to the number of feet treated)
Measured: 9 months
Partial and total success rate (relative to the number of patients treated)
- Total success rate: (number of patients with unilateral involvement and foot treated successfully + number of patients with bilateral involvement and both feet treated successfully) / total number of patients.
- Partial success rate in patients with bilateral involvement: number of patients with only one of the 2 feet treated successfully / number of patients with bilateral involvement.
Measured: 9 months
Convex angle of the outer edge of the foot during follow-up
The evolution of the convexity angle of the external edge of the foot will be studied during treatment and follow-up, in a mixed model with repeated measurements, with the initial severity of the malformation as a cofactor (angle ≤ 15 ° /> 15 ° ).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start18 Jul 2020
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DeformitiesStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mira MD RAMANOUDJAME, Principal investigator, Clinique Marcel SEMBAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312828
- Sponsor's protocol ID
- 2019-A02916-51
- Status last verified
- Aug 2022
- First submitted
- 16 Mar 2020
- Last updated
- 15 Aug 2022
- 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 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Orthopedic Care of the Z-shaped Foot in Children From 6 Months to 2 Years Old
- ClinicalTrials.gov ID
- NCT04312828
- Acronym / sponsor ID
- 2019-A02916-51
- Conditions
- Foot Deformities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 18 Jul 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 18 Mar 2020 (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.
Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.
Detailed description
The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.
Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who suffered from a congenital idiopathic Z-foot deformation, aged 6 months to 2 years at the time of orthopedic treatment.
Key inclusion criteria (4 listed)
- Child having presented a congenital idiopathic malformation uni- or bilateral of foot in Z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump;
- Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion;
- Child aged 6 months to 2 years at the start of care;
- Authorization of the parents or the legal representative of the child to collect personal information about their child.
Key exclusion criteria (4 listed)
- Child having presented a secondary Z foot;
- History of foot surgery;
- Lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care;
- Inability of the parents or the child's legal representative to understand the study protocol.
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 |
|---|---|---|
| Orthopedic management of the Z-footOrthopedic treatment with femoropedic plasters and slotted splints in 1st intention | Procedure or surgery | – |
Primary outcome
The main criterion of the study is the success rate of orthopedic management of the Z-foot.
Time frame: 9 months
Success is a composite criterion, measured at the last follow-up, defined by: * Outer edge of the straight foot; AND * Absence of dorsolateral hump OR possibility of putting on shoes without difficulty AND * Absence of recurrence of the malformation OR resumption of surgery OR resumption of orthopedic treatment.
3 secondary outcomes
Moderate success rate of the procedure
Time frame: 9 months
Partial and total success rate (relative to the number of patients treated)
Time frame: 9 months
Convex angle of the outer edge of the foot during follow-up
Time frame: 9 months
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 15 Aug 2022.
- 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. This study is not recruiting at the moment.
Mira MD RAMANOUDJAME principal investigator
Clinique Marcel SEMBAT
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 Foot Deformities, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 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 15 Aug 2022. 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?
The main criterion of the study is the success rate of orthopedic management of the Z-foot. (time frame: 9 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 15 Aug 2022.