Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark

Cerebral Palsy Clinical Trial

Official title:

Prediction of Hip Displacement in Children With Cerebral Palsy Among Patients Participating in the Danish Cerebral Palsy Follow-up Program

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04403178
• Other study ID #: P-2019-143 2
• Status: Enrolling by invitation
• Start date: January 1, 2008
• Est. completion date: December 27, 2020

Study information

• Verified date: July 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Child
• Hip Dislocation
• Hip Displacement
• Paralysis
• Prospective Studies
• Radiography

Intervention

Diagnostic Test:
• Radiographic examination with a Migration of > 40 %
Radiographic examination

Locations

Country	Name	City	State
Denmark	Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital	Hvidovre	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Mette Røn Kristensen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Hägglund 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. — View Citation

Hermanson M, Hägglund 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. — View Citation

Rasmussen HM, Nordbye-Nielsen K, Møller-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. eCollection 2016. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Follow-up period of three years.