Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-Centre Prospective Comparative Cohort Study (CHOP-II)

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 19
Healthy Volunteers: f
View:

• Children with severe, non-ambulant (GMFCS IV \& V) Cerebral Palsy

• between 2 and 19 years of age

• with radiographic evidence of hip displacement (previously untreated) as measured by Reimer's MP ≥ 30%

• and their parents or primary caregivers, defined as the individual most involved in the daily care of the child are willing to complete the CPCHILD in one of the available languages the CPCHILD is offered in

Locations
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Unni G Narayanan, MD
unni.narayanan@sickkids.ca
416-813-6432
Backup
Ashley Ferkul
ashley.ferkul@sickkids.ca
416-813-6608
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 1000
Treatments
Natural History or watchful waiting
Serial botulinum toxin injections
Adductor (+/- psoas) muscle releases alone
Hip reconstructive surgery
Salvage hip surgery
Related Therapeutic Areas
Sponsors
Collaborators: Shriners Hospitals for Children, Honolulu, Nuffield Orthopaedic Centre NHS Trust, Children's Hospital Medical Center, Cincinnati, Alfred I. duPont Hospital for Children, Shriners Hospitals for Children, Sacramento, The Royal London Hospital, Shriners Hospitals for Children,Canada, Morgan Stanley Children's Hospital, Skane University Hospital, Aarhus University Hospital, Provincial Health Services Authority, Columbia University, Boston Children's Hospital, Seoul National University Bundang Hospital, University of Nebraska, Sheba Medical Center, Children's Hospital Colorado, Poznan University of Medical Sciences, Karolinska University Hospital, Royal Children's Hospital, Alder Hey Children's NHS Foundation Trust, Starship Children's Hospital of New Zealand, Great Ormond Street Hospital for Children NHS Foundation Trust, IWK Health Centre, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Hospital for Special Surgery, New York, Gillette Children's Specialty Healthcare, Children's Health Queensland Hospital and Health Service
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov