Cerebral PalsyNCT02372617
Hip Reconstruction in Cerebral Palsy With Pelvic Osteotomy
An observational study of Cerebral Palsy, run by Associação de Assistência a Criança Deficiente at 1 site in Brazil.
Trial summary
Prospective study enrolling patients with cerebral palsy and with subluxation of the hips > 40% and acetabular dysplasia. The patients will be stratified according the degree of subluxation and age. The treatment protocol is composed by femur variation osteotomy and periacetabular osteotomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- periacetabular osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cerebral palsy of AACD Cerebral Palsy Clinic, with progressive hip subluxation.
Who may be able to join
- hip subluxation > 40% and acetabular dysplasia
Who cannot join
- previous hip surgery
Trial locations and contacts
1 site in 1 country.
About this study
Prospective study enrolling patients with cerebral palsy and with subluxation of the hips > 40% and acetabular dysplasia. The patients will be stratified according the degree of subluxation and age. The treatment protocol is composed by femur variation osteotomy and periacetabular osteotomy. Patients will be divided in two groups according the type of bone graft used at periacetabular osteotomy (autologous or ceramic).
- Conditions
- Cerebral Palsy
- Being tested
- periacetabular osteotomy
- Keywords
- cerebral palsy, hip, luxation, subluxation
- Medical subject headings
- Cerebral Palsy, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periacetabular osteotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | bone graft - autologous Receives: Procedure: periacetabular osteotomy | |
| Group B | bone graft - ceramic Receives: Procedure: periacetabular osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular index
Measured: 12 months
Secondary outcomes (1)
Reimers Index
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação de Assistência a Criança Deficiente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Cesar de Morais Filho, Associação de Assistência a Criança Deficiente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372617
- Sponsor's protocol ID
- AACD 30/2011
- Status last verified
- Jun 2018
- First submitted
- 22 Feb 2015
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Reconstruction in Cerebral Palsy With Pelvic Osteotomy
- ClinicalTrials.gov ID
- NCT02372617
- Acronym / sponsor ID
- AACD 30/2011
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, hip, luxation, subluxation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Associação de Assistência a Criança DeficienteUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Feb 2015 (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.
Prospective study enrolling patients with cerebral palsy and with subluxation of the hips > 40% and acetabular dysplasia. The patients will be stratified according the degree of subluxation and age. The treatment protocol is composed by femur variation osteotomy and periacetabular osteotomy. Patients will be divided in two groups according the type of bone graft used at periacetabular osteotomy (autologous or ceramic).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: periacetabular osteotomybone graft - autologous |
| Group B | – | Procedure: periacetabular osteotomybone graft - ceramic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cerebral palsy of AACD Cerebral Palsy Clinic, with progressive hip subluxation.
Key inclusion criteria (1 listed)
- hip subluxation > 40% and acetabular dysplasia
Key exclusion criteria (1 listed)
- previous hip surgery
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 |
|---|---|---|
| periacetabular osteotomy | Procedure or surgery | Group A, Group B |
Primary outcome
Acetabular index
Time frame: 12 months
1 secondary outcome
Reimers Index
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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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 Cerebral Palsy, run by Associação de Assistência a Criança Deficiente at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 27 Jun 2018. 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 Brazil. 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?
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?
Acetabular index (time frame: 12 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 27 Jun 2018.