ChildNCT04403178
Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark
An observational study of Child and Cerebral Palsy, run by Mette Røn Kristensen at 1 site in Denmark.
Trial summary
Children with cerebral palsy have an increased risk of hip dislocation, which is a painful and severe complication of cerebral palsy. The 20-years evaluation of the Swedish surveillance programme shows that hip dislocation in children with cerebral palsy can be prevented with regular clinical and radiographic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child, Cerebral Palsy, Radiography
- What is being tested?
- Radiographic examination with a Migration of > 40 %
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2008to 27 Dec 2020
- 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: Children with cerebral palsy in Denmark. Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.
Who may be able to join
- Children with cerebral palsy
- Gross Motor Function Classification System III to V
- Migration Percentage < 40 % for both hips at the first pelvic radiographic examination
Who cannot join
- Previous femoral osteotomy
- Previous pelvic osteotomy
- Previous selective dorsal rhizotomy
- Intrathecal baclofen pump treatment
- Children whose diagnosis was not confirmed
- Children who were no longer followed in the children's ward at the hospital
- Children who moved out of the area
- Children who died during the study period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital
Hvidovre, Capital Region, 2650
About this study
Official title: Prediction of Hip Displacement in Children With Cerebral Palsy Among Patients Participating in the Danish Cerebral Palsy Follow-up Program
Children with cerebral palsy have an increased risk of hip dislocation, which is a painful and severe complication of cerebral palsy. The 20-years evaluation of the Swedish surveillance programme shows that hip dislocation in children with cerebral palsy can be prevented with regular clinical and radiographic examination and early intervention.
We would like to determine the individual risk for hip displacement for Danish children with CP in The Danish Cerebral Palsy Follow-up Program. This could be a valuable clinical tool in deciding on further follow-up and treatment.
Read the detailed description
Migration percentage (MP) which is measured from the pelvis radiograph is commonly used to assess lateral displacement of the femoral head and is being used in the Swedish and in the Danish surveillance programme. Most children with an MP > 40 % need surgery to prevent further displacement and prevent dislocation of the hip. In the Swedish surveillance programme they have developed the Cerebral Palsy Follow-Up Programme (CPUP) hip score as a risk score to determine which children are at high or low risk for hip displacement (MP > 40 %) within five years after first radiographic examination.
The aim of this study is to predict the likelihood that a child with cerebral palsy will develop hip displacement (MI> 40) within three years. The design is a prediction study.
Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.
- Conditions
- Child, Cerebral Palsy, Radiography, Hip Dislocation, Hip Displacement, Prospective Studies
- Being tested
- Radiographic examination with a Migration of > 40 %
- Medical subject headings
- Cerebral Palsy, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic examination with a Migration of > 40 %Diagnostic test
Radiographic examination
| Study group | Role | What they receive |
|---|---|---|
| Children who develops hip displacement | Patient group 1 includes children who developed a Migration Percentage of > 40 % in either hip over a follow-up period of three years. | |
| Children who do not develops hip displacement | Patient group 2 includes children who did not develop a Migration Percentage of > 40 % on either hip over a follow-up period of three years Receives: Diagnostic Test: Radiographic examination with a Migration of > 40 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of hip displacement or not measured by the Migration Percentage
Migration Percentage (MP) is measured from a pelvis radiograph and is used to assess lateral displacement of the femoral head. A MP < 40 % on either hip is a good outcome, whereas a MP > 40 % on either hip is a worse outcome.
Measured: Follow-up period of three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jan 2008
- Primary completion27 May 2020
- Study completion27 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ChildStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mette Røn Kristensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mette Røn Kristensen, Hvidovre University Hospital
- Investigators
- Mette Røn Kristensen, PT, MSc, Principal investigator, Afsnit 234- 236, Fysio- og ergoterapien, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403178
- Sponsor's protocol ID
- P-2019-143 2
- Status last verified
- Jul 2020
- First submitted
- 15 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hermanson M, Hagglund G, Riad J, Rodby-Bousquet E, Wagner P. Prediction of hip displacement in children with cerebral palsy: development of the CPUP hip score. Bone Joint J. 2015 Oct;97-B(10):1441-4. doi: 10.1302/0301-620X.97B10.35978.
PubMed 26430023Rasmussen HM, Nordbye-Nielsen K, Moller-Madsen B, Johansen M, Ellitsgaard N, Pedersen CR, Rackauskaite G, Engberg H, Pedersen NW. The Danish Cerebral Palsy Follow-up Program. Clin Epidemiol. 2016 Oct 25;8:457-460. doi: 10.2147/CLEP.S99474. eCollection 2016.
PubMed 27822084Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
PubMed 25371472
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hip Displacement in Children With Cerebral Palsy Among Patients Participating in the Danish Cerebral Palsy Follow-up Program
- ClinicalTrials.gov ID
- NCT04403178
- Acronym / sponsor ID
- P-2019-143 2
- Conditions
- Child, Cerebral Palsy, Radiography, Hip Dislocation, Hip Displacement, Prospective Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mette Røn KristensenUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 Dec 2020 (estimated)
- First posted
- 27 May 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.
Children with cerebral palsy have an increased risk of hip dislocation, which is a painful and severe complication of cerebral palsy. The 20-years evaluation of the Swedish surveillance programme shows that hip dislocation in children with cerebral palsy can be prevented with regular clinical and radiographic examination and early intervention.
We would like to determine the individual risk for hip displacement for Danish children with CP in The Danish Cerebral Palsy Follow-up Program. This could be a valuable clinical tool in deciding on further follow-up and treatment.
Detailed description
Migration percentage (MP) which is measured from the pelvis radiograph is commonly used to assess lateral displacement of the femoral head and is being used in the Swedish and in the Danish surveillance programme. Most children with an MP > 40 % need surgery to prevent further displacement and prevent dislocation of the hip. In the Swedish surveillance programme they have developed the Cerebral Palsy Follow-Up Programme (CPUP) hip score as a risk score to determine which children are at high or low risk for hip displacement (MP > 40 %) within five years after first radiographic examination.
The aim of this study is to predict the likelihood that a child with cerebral palsy will develop hip displacement (MI> 40) within three years. The design is a prediction study.
Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children who develops hip displacement | – | –Patient group 1 includes children who developed a Migration Percentage of > 40 % in either hip over a follow-up period of three years. |
| Children who do not develops hip displacement | – | Diagnostic Test: Radiographic examination with a Migration of > 40 %Patient group 2 includes children who did not develop a Migration Percentage of > 40 % on either hip over a follow-up period of three years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with cerebral palsy in Denmark. Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.
Key inclusion criteria (3 listed)
- Children with cerebral palsy
- Gross Motor Function Classification System III to V
- Migration Percentage < 40 % for both hips at the first pelvic radiographic examination
Key exclusion criteria (8 listed)
- Previous femoral osteotomy
- Previous pelvic osteotomy
- Previous selective dorsal rhizotomy
- Intrathecal baclofen pump treatment
- Children whose diagnosis was not confirmed
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 |
|---|---|---|
| Radiographic examination with a Migration of > 40 %Radiographic examination | Diagnostic test | Children who do not develops hip displacement |
Primary outcome
Development of hip displacement or not measured by the Migration Percentage
Time frame: Follow-up period of three years.
Migration Percentage (MP) is measured from a pelvis radiograph and is used to assess lateral displacement of the femoral head. A MP < 40 % on either hip is a good outcome, whereas a MP > 40 % on either hip is a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 26430023Hermanson M, Hagglund G, Riad J, Rodby-Bousquet E, Wagner P. Prediction of hip displacement in children with cerebral palsy: development of the CPUP hip score. Bone Joint J. 2015 Oct;97-B(10):1441-4. doi: 10.1302/0301-620X.97B10.35978.
- Background: PubMed 27822084Rasmussen HM, Nordbye-Nielsen K, Moller-Madsen B, Johansen M, Ellitsgaard N, Pedersen CR, Rackauskaite G, Engberg H, Pedersen NW. The Danish Cerebral Palsy Follow-up Program. Clin Epidemiol. 2016 Oct 25;8:457-460. doi: 10.2147/CLEP.S99474. eCollection 2016.
- Background: PubMed 25371472Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
- 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.
Mette Røn Kristensen, PT, MSc principal investigator
Afsnit 234- 236, Fysio- og ergoterapien, Hvidovre Hospital
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 Child and Cerebral Palsy, run by Mette Røn Kristensen at 1 site in Denmark.
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 3 inclusion and 8 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 29 Jul 2020. 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 Denmark. 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?
Development of hip displacement or not measured by the Migration Percentage (time frame: Follow-up period of three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403178, which also lists 3 linked publications.
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 29 Jul 2020.