Clinical Trial

Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy

Study acronym: CHOP II
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 11, 2021 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Children with severe cerebral palsy (CP) are at high risk for progressive hip displacement, associated with pain and contractures interfering with many aspects of care, comfort and quality of life. These children undergo many types of interventions, the optimal timing and effectiveness of which, remain unclear. In 2014, CIHR funded the CP Hip Outcomes Project (CHOP), an international multi-centre prospective longitudinal cohort study of children with severe (non-ambulant) CP with evidence of hip displacement defined as a Reimer's migration percentage (MP) of at least 30%. The study was designed to evaluate the comparative effectiveness of different treatment strategies to prevent or relieve symptoms associated with hip instability, using the validated Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD ) questionnaire as the primary outcome measure of health-related quality of life © (HRQL) for this population. 650 patients enrolled from 28 sites in 11 countries, are actively being followed and will reach at least 2 years of follow-up at the end of 2019. This project, will study the impact of hip instability and its management in children with severe CP using the CPCHILD questionnaire that was developed specifically for this purpose. Although CHOP will define outcomes at 24 months, the outcomes are not expected to remain stable while the child is still growing. The inception cohort will need follow-up until skeletal maturity to track their long-term outcome trajectories.
Trial Details
NCT Number NCT04792606
Lead Sponsor The Hospital for Sick Children
Collaborators: Royal Children's Hospital, Shriners Hospitals for Children,Canada, Provincial Health Services Authority British Columbia, Aarhus University Hospital, Sheba Medical Center, Seoul National University Bundang Hospital, Starship Children's Hospital of New Zealand, Poznan University of Medical Sciences, Skane University Hospital, Karolinska University Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, The Royal London Hospital, Nuffield Orthopaedic Centre NHS Trust, Children's Hospital Medical Center, Cincinnati, Boston Children's Hospital, Columbia University, Shriners Hospitals for Children, Sacramento, Gillette Children's Specialty Healthcare, Alfred I. duPont Hospital for Children, IWK Health Centre, Alder Hey Children's NHS Foundation Trust, Children's Hospital Colorado, Hospital for Special Surgery, New York, Shriners Hospitals for Children, Honolulu, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Morgan Stanley Children's Hospital, Children's Health Queensland Hospital and Health Service, University of Nebraska
Conditions Cerebral Palsy
Enrollment 1,000 participants
Start Date 2019-10-01
Primary Completion 2026-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2021-03-11