ClubfootNCT03580746
Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results
An observational study of Clubfoot, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. Read more about this study
- Who is it for?
- Ages 2 days to 18 years
- Conditions the study is for
- Clubfoot
- What is being tested?
- Taping and posteromedial release and Ponseti
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Aug 2015
- 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 2 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Retrospective study of children with club foots treated by two different options.
Who may be able to join
- All patients with talipes equinovarus who have been treated at our institution
Who cannot join
- Patients with other disorders which may influence the clinical or gait analysis outcome
Trial locations and contacts
1 site in 1 country.
About this study
There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the investigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release.
Read the detailed description
There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the invistigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release. Trial objectives With this study the investigators would like to investigate whether clinical results and gait analysis in patients treated with Ponseti has better results compared to patients treated with the older methods.
- Conditions
- Clubfoot
- Being tested
- Taping and posteromedial release, Ponseti
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taping and posteromedial releaseProcedure or surgery
PonsetiProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Taping and posteromedial release | Children with clubfoots are treated by taping and posteromedial release Receives: Procedure: Taping and posteromedial release | |
| Treatment by Ponseti | Children with clubfoots are treated by Ponseti Receives: Procedure: Ponseti |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical results
Different clinical results between the two groups using AOFAS (American Orthopaedic Foot and Ankle Society) score.
Measured: 1 year
Secondary outcomes (1)
Gait analysis
Differences in gait analysis between the two groups. While walking barefoot following parameters will be compared: ranges of motion occurring at each joint and each sub phase of stance
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 posted9 Jul 2018
- Study startSep 2014 (estimated)
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: Resident working on this study left our department
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580746
- Sponsor's protocol ID
- UZLeuvenColette
- Status last verified
- Mar 2021
- First submitted
- 23 Sep 2014
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results
- ClinicalTrials.gov ID
- NCT03580746
- Acronym / sponsor ID
- UZLeuvenColette
- Conditions
- Clubfoot
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resident working on this study left our department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2014 (estimated)
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 9 Jul 2018 (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.
There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the investigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release.
Detailed description
There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the invistigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release. Trial objectives With this study the investigators would like to investigate whether clinical results and gait analysis in patients treated with Ponseti has better results compared to patients treated with the older methods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taping and posteromedial release | – | Procedure: Taping and posteromedial releaseChildren with clubfoots are treated by taping and posteromedial release |
| Treatment by Ponseti | – | Procedure: PonsetiChildren with clubfoots are treated by Ponseti |
Who may qualify
- Ages
- 2 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Retrospective study of children with club foots treated by two different options.
Key inclusion criteria (1 listed)
- All patients with talipes equinovarus who have been treated at our institution
Key exclusion criteria (1 listed)
- Patients with other disorders which may influence the clinical or gait analysis outcome
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 |
|---|---|---|
| Taping and posteromedial release | Procedure or surgery | Taping and posteromedial release |
| Ponseti | Procedure or surgery | Treatment by Ponseti |
Primary outcome
Clinical results
Time frame: 1 year
Different clinical results between the two groups using AOFAS (American Orthopaedic Foot and Ankle Society) score.
1 secondary outcome
Gait analysis
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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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.
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?
An observational study of Clubfoot, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: withdrawn, as of the sponsor's last update on 2 Mar 2021. 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 Belgium. 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 withdrawn before enrolling participants, so there are no results.
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?
Clinical results (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 2 Mar 2021.