ClubfootNCT02815306
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot
A study testing Polyaxial brace in people with Clubfoot, run by Children's Hospital of Chongqing Medical University.
Trial summary
Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. Read more about this study
- Who is it for?
- Ages 1 day to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- Polyaxial brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Oct 2013
- 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 1 day to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0-6 months infants parents would like to cooperate with the doctors.
Who cannot join
- over 6 months.
About this study
Official title: Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants
Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.
Read the detailed description
Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment.
- Conditions
- Clubfoot
- Being tested
- Polyaxial brace
- Keywords
- Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyaxial braceDevice
The Polyaxial brace were made by a technician trained by the China National Disabled Persons Federation. For all patients, gypsum models were prepared first, and then braces were fabricated according to the models. The detailed technique was fully in accordance with the Ponseti method.
| Study group | Role | What they receive |
|---|---|---|
| Brace goup | Experimental | The infants who were brace group treated by braces which were designed and made by us. Receives: Device: Polyaxial brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
hindfoot
severity of the posterior crease, emptiness of the heel and rigidity of the equinus
Measured: 1 month
midfoot
curvature of the lateral border of the foot, severity of the medial crease and position of the lateral part of the head of the talus
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionOct 2013
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxin Nan, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815306
- Sponsor's protocol ID
- Guoxin CFB-2016
- Status last verified
- Jun 2016
- First submitted
- 24 Mar 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants
- ClinicalTrials.gov ID
- NCT02815306
- Acronym / sponsor ID
- Guoxin CFB-2016
- Conditions
- Clubfoot
- Keywords
- Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 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.
Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.
Detailed description
Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brace goup | Experimental | Device: Polyaxial braceThe infants who were brace group treated by braces which were designed and made by us. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 0-6 months infants parents would like to cooperate with the doctors.
Key exclusion criteria (1 listed)
- over 6 months.
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 |
|---|---|---|
| Polyaxial braceThe Polyaxial brace were made by a technician trained by the China National Disabled Persons Federation. For all patients, gypsum models were prepared first, and then braces were fabricated according to the models. The detailed technique was fully in accordance with the Ponseti method. | Device | Brace goup |
Primary outcome
hindfoot
Time frame: 1 month
severity of the posterior crease, emptiness of the heel and rigidity of the equinus
midfoot
Time frame: 1 month
curvature of the lateral border of the foot, severity of the medial crease and position of the lateral part of the head of the talus
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 28 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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 Polyaxial brace in people with Clubfoot, run by Children's Hospital of Chongqing Medical University.
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: finished, as of the sponsor's last update on 28 Jun 2016. 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. 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?
hindfoot (time frame: 1 month). 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 28 Jun 2016.