Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy (CHOP II)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy

Detailed Description

Background: 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, unique in scale and design, will study the impact of hip instability and its management in children with severe CP using a meaningful outcome measure 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. The international network of investigators/sites and the infrastructure established for CHOP will facilitate the long-term follow-up of the participants in this study. In addition, the results of CHOP will inform the design of nested trials to evaluate the effectiveness of future interventions aimed at improving the quality of life of children with severe disabilities.

Study Aims Aim 1: Measure the post 24-month effectiveness of different treatment strategies for hip displacement in children with severe CP using the CPCHILD as the primary outcome measure.

Aim 2: Compare the rates of recurrence, relapse of symptoms, additional interventions and other longer term complications associated with each of the treatment cohorts.

Methods

Study Design: Multi-centre longitudinal cohort study of children with severe (non-ambulant) CP, ages 3 to 18 years with hip MP ≥ 30% enrolled in one of 5 cohorts:

A. "Natural" History or watchful waiting B. Serial botulinum toxin injections C. Adductor (+/- psoas) muscle releases alone D. Hip reconstructive surgery E. Salvage hip surgery Data collected include demographics, prognostic factors, including co-morbid conditions, parental reports of HRQL as measured by the CPCHILD, and radiographic measures of MP and acetabular index (AI). The primary outcome measure CPCHILD, as well as the MP & AI will be assessed every 12 months after the 24 month follow-up since inception in CHOP. The cohort of 650 children enrolled in Groups B, C, D, & E will be compared with each other as well as with their respective propensity matched counterparts of untreated children (Group A), using repeated measures ANOCOVA at 3yrs, and annually thereafter until at least 5 years of follow-up or skeletal maturity.

Significance: CHOP I & II will establish the superiority of either prophylactic or reactive intervention strategies for hip displacement in severe CP and provide justification for hip surveillance.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Unni G Narayanan, MD; Phone Number: 416-813-6432; Email: unni.narayanan@sickkids.ca
• Study Contact Backup: Name: Ashley Ferkul; Phone Number: 416-813-6608; Email: ashley.ferkul@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Unni G Narayanan, MD; Phone Number: 416 813 6432; Email: unni.narayanan@sickkids.ca
      • Contact: Ashley Ferkul, BA; Phone Number: 416-813-6608; Email: ashley.ferkul@sickkids.ca
      • Principal Investigator: Unni G Narayanan, MBBS, MSc, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children between the ages of 2 and 19 with severe cerebral palsy (defined as a GMFCS level or IV or V) experiencing hip displacement (with radiographic evidence of a migration percentage (MP) or 30%) will be recruited to be apart of the CHOP II study.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• under the age of 2, or over the age of 19
• Reimer's migration percentage under 30% in both hips
• parents or primary caregivers unable to complete the CPCHILD in one of it's available languages

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
"Natural" History or watchful waiting
Serial botulinum toxin injections
Adductor (+/- psoas) muscle releases alone
Hip reconstructive surgery
Salvage hip surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)	The CPCHILD questionnaire is intended for persons with CP who rely on a wheelchair for most of their mobility. The CPCHILD questionnaire assesses how parents or caregivers rate their child (or how a child rates him/herself when able) about various issues related to daily activities, self care, getting around, comfort, communication, social interaction and health. The CPCHILD also identifies which of these issues the parents (or the child) feel are important to improve.	The CPCHILD takes approximately 15 minutes to complete

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Karolinska University Hospital; Aarhus University Hospital; Columbia University; Children's Hospital Colorado; Boston Children's Hospital; Seoul National University Bundang Hospital; Children's Hospital Medical Center, Cincinnati; Sheba Medical Center; Hospital for Special Surgery, New York; Poznan University of Medical Sciences; University of Nebraska; Morgan Stanley Children's Hospital; Royal Children's Hospital; IWK Health Centre; Provincial Health Services Authority; Skane University Hospital; Great Ormond Street Hospital for Children NHS Foundation Trust; Alder Hey Children's NHS Foundation Trust; Alfred I. duPont Hospital for Children; Shriners Hospitals for Children,Canada; Starship Children's Hospital of New Zealand; The Royal London Hospital; Nuffield Orthopaedic Centre NHS Trust; Shriners Hospitals for Children, Sacramento; Gillette Children's Specialty Healthcare; Shriners Hospitals for Children, Honolulu; Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust; Children's Health Queensland Hospital and Health Service
• Investigators: Principal Investigator: Unni G Narayanan, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): March 31, 2026
• Study Completion (Anticipated): March 31, 2028

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: non-ambulatory, non-ambulatory cerebral palsy, patient reported outcomes measures, PROMS, outcomes, CPCHILD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 420492

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