Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark

NCT04403178 | Unknown DMC

• 1 other identifier: P-2019-143 2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child; Cerebral Palsy; Radiography; Hip Dislocation; Hip Displacement; Prospective Studies

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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 %

Interventions

Radiographic examination with a Migration of > 40 % DIAGNOSTIC_TEST

Radiographic examination

Children who do not develops hip displacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mette Røn Kristensen: lead

Study Sites (1)

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

Hvidovre, Capital Region, 2650, Denmark

Location

Related Publications (3)

• 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.

  PMID: 26430023 BACKGROUND

• 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.

  PMID: 27822084 BACKGROUND

• 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.

  PMID: 25371472 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mette Røn Kristensen, PT, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regional coordinator for CPOP in the capital region of Denmark

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 27, 2020
• Study Start: January 1, 2008
• Primary Completion: May 27, 2020
• Study Completion: December 27, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)