Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark

NCT ID: NCT04403178

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2020-12-27

Brief Summary

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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

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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

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Child Cerebral Palsy Radiography Hip Dislocation Hip Displacement Prospective Studies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

Radiographic examination with a Migration of > 40 %

Intervention Type DIAGNOSTIC_TEST

Radiographic examination

Interventions

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Radiographic examination with a Migration of > 40 %

Radiographic examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children with cerebral palsy
* Gross Motor Function Classification System III to V
* Migration Percentage \< 40 % for both hips at the first pelvic radiographic examination

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mette Røn Kristensen

OTHER

Sponsor Role lead

Responsible Party

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Mette Røn Kristensen

Regional coordinator for CPOP in the capital region of Denmark

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mette Røn Kristensen, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Afsnit 234- 236, Fysio- og ergoterapien, Hvidovre Hospital

Locations

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Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital

Hvidovre, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 26430023 (View on PubMed)

Rasmussen 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.

Reference Type BACKGROUND
PMID: 27822084 (View on PubMed)

Hagglund 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.

Reference Type BACKGROUND
PMID: 25371472 (View on PubMed)

Other Identifiers

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P-2019-143 2

Identifier Type: -

Identifier Source: org_study_id

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