Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Child; Hip Dislocation; Radiography; Prospective Studies; Hip Displacement
• Intervention / Treatment: Diagnostic test: Radiographic examination with a Migration of > 40 %

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Denmark
  • Region Hovedstaden
    • Hvidovre, Region Hovedstaden, Denmark, 2650
      • Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Radiographic examination with a Migration of > 40 %; Radiographic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Mette Røn Kristensen
• Investigators: Principal Investigator: Mette Røn Kristensen, PT, MSc, Afsnit 234- 236, Fysio- og ergoterapien, Hvidovre Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ACTUAL): May 27, 2020
• Study Completion (ANTICIPATED): December 27, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Brain Damage, Chronic; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Joint Dislocations; Cerebral Palsy; Hip Dislocation; Paralysis
• Other Study ID Numbers: P-2019-143 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No