Recurrent ClubfootNCT04212663
A Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
A study testing The tendon release of musculi tibialis posterior, Anterior tibial tendon transfer(TATT) and Achilles tendon lengthing in people with Recurrent Clubfoot, run by Guangzhou Women and Children's Medical Center.
Trial summary
The musculi tibialis posterior can adduct the foot, so releasing the tedon of the muscle can help to correct the deformity of the forefoot adduction. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Recurrent Clubfoot
- What is being tested?
- The tendon release of musculi tibialis posterior, Anterior tibial tendon transfer(TATT) and Achilles tendon lengthing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 25 Sep 2021
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of recurrent idiopathic clubfoot
- The initial treatment was treated with the ponseti method
- Dynamic supination
- The max-dorsiflexion of angle <5°
- The fore foot is adduct
- The sole is cavus
Who cannot join
- Symptomatic recurrent clubfoot
- Tarsal fusion
- Rigid recurrent clubfoot
About this study
Official title: A Multicenter Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
The musculi tibialis posterior can adduct the foot, so releasing the tedon of the muscle can help to correct the deformity of the forefoot adduction.
- Conditions
- Recurrent Clubfoot
- Being tested
- The tendon release of musculi tibialis posterior, Anterior tibial tendon transfer(TATT), Achilles tendon lengthing, Fascial release
- Keywords
- Musculi tibialis posterior, Tendon release, Anterior tibial tendon transfer
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The tendon release of musculi tibialis posteriorProcedure or surgery
To release the tendon of musculi tibialis posterior.
Anterior tibial tendon transfer(TATT)Procedure or surgery
To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.
Achilles tendon lengthingProcedure or surgery
To lengthen the achilles tendon by using two incisions.
Fascial releaseProcedure or surgery
To cut off the metatarsal fascia in the middle part.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release Receives: Procedure: Anterior tibial tendon transfer(TATT); Procedure: Achilles tendon lengthing; Procedure: Fascial release |
| experiment | Experimental | receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release+ The tendon release of musculi tibialis posterior Receives: Procedure: The tendon release of musculi tibialis posterior; Procedure: Anterior tibial tendon transfer(TATT); Procedure: Achilles tendon lengthing; Procedure: Fascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adduction of foot.
Measure the angle of foot adduction
Measured: Six months after the operation
The adduction of foot.
Measure the angle of foot adduction
Measured: 1 year after operation
Secondary outcomes (2)
The dorsiflextion of ankle.
Measure the angle of ankle dorsiflextion
Measured: Six months after the operation
The dorsiflextion of ankle.
Measure the angle of ankle dorsiflextion
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion25 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwen Xu, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212663
- Sponsor's protocol ID
- GuangzhouWCMC-002
- Status last verified
- Dec 2019
- First submitted
- 21 Sep 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
- ClinicalTrials.gov ID
- NCT04212663
- Acronym / sponsor ID
- GuangzhouWCMC-002
- Conditions
- Recurrent Clubfoot
- Keywords
- Musculi tibialis posterior, Tendon release, Anterior tibial tendon transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 25 Sep 2021 (estimated)
- First posted
- 27 Dec 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.
The musculi tibialis posterior can adduct the foot, so releasing the tedon of the muscle can help to correct the deformity of the forefoot adduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Procedure: Anterior tibial tendon transfer(TATT), Procedure: Achilles tendon lengthing, Procedure: Fascial releasereceive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release |
| experiment | Experimental | Procedure: The tendon release of musculi tibialis posterior, Procedure: Anterior tibial tendon transfer(TATT), Procedure: Achilles tendon lengthing, Procedure: Fascial releasereceive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release+ The tendon release of musculi tibialis posterior |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Clinical diagnosis of recurrent idiopathic clubfoot
- The initial treatment was treated with the ponseti method
- Dynamic supination
- The max-dorsiflexion of angle <5°
- The fore foot is adduct
Key exclusion criteria (3 listed)
- Symptomatic recurrent clubfoot
- Tarsal fusion
- Rigid recurrent clubfoot
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 |
|---|---|---|
| The tendon release of musculi tibialis posteriorTo release the tendon of musculi tibialis posterior. | Procedure or surgery | experiment |
| Anterior tibial tendon transfer(TATT)To transfer the the tendon of anterior tibial from the navicular to the third cuneiform. | Procedure or surgery | control, experiment |
| Achilles tendon lengthingTo lengthen the achilles tendon by using two incisions. | Procedure or surgery | control, experiment |
| Fascial releaseTo cut off the metatarsal fascia in the middle part. | Procedure or surgery | control, experiment |
Primary outcome
The adduction of foot.
Time frame: Six months after the operation
Measure the angle of foot adduction
The adduction of foot.
Time frame: 1 year after operation
Measure the angle of foot adduction
2 secondary outcomes
The dorsiflextion of ankle.
Time frame: Six months after the operation
The dorsiflextion of ankle.
Time frame: 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The tendon release of musculi tibialis posterior, Anterior tibial tendon transfer(TATT) and Achilles tendon lengthing in people with Recurrent Clubfoot, run by Guangzhou Women and Children's Medical Center.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 adduction of foot. (time frame: Six months after the operation). The study lists 2 primary outcomes in all. 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 27 Dec 2019.