SCFE Longitudinal International Prospective Registry

NCT ID: NCT04117841

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2028-05-31

Brief Summary

Slipped Capital Femoral Epiphysis (SCFE) is the most common disorder of the adolescent hip and diagnosis and treatment of SCFE remain areas of controversy and investigation. The current issues relating to diagnosis stem from an inability to diagnose the condition early on, resulting in increased morbidity. Once diagnosed, there are multiple different options for surgical treatment, including in-situ pinning, and the Modified Dunn procedure. Research is ongoing to determine the parameters that should be considered when selecting a procedure to ensure an ideal outcome. In particular, there is a focus on investigating which treatment method may result in lower incidence of avascular necrosis of the femoral head and femoroacetabular impingement (FAI), two significant long term concerns associated with SCFE. Despite myriad published studies on SCFE, very few are prospective and most lack sufficient patient numbers for clinically meaningful comparative analysis. The aim of this study is to develop a multi-center, international prospective registry of patients with SCFE to facilitate the comprehensive examination of clinical, functional and radiographic outcomes of each treatment, in relation to specific parameters determined prior to intervention. The general registry will serve as a hypothesis-generating database of prospectively collected outcomes. In turn, this will facilitate the development of targeted, hypothesis-testing randomized controlled trials and observational studies that can be housed within the larger registry.

Conditions

Slipped Capital Femoral Epiphyses; SCFE

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm I: Prospective from diagnosis

Patients have been enrolled and followed since diagnosis will be placed into Arm I.

Observational

Intervention Type: OTHER

All groups will undergo observational data collection. No interventions will be made to patient care.

Arm II: Prior treatment at centre

Patients who have received previous treatment and will continue to receive treatment at the participating center will be placed into Arm II.

Observational

Intervention Type: OTHER

All groups will undergo observational data collection. No interventions will be made to patient care.

Arm III: Prior treatment at outside centre

Patients who have received previous treatment at an outside center but are continuing treatment at a participating center will be placed into Arm III.

Observational

Intervention Type: OTHER

All groups will undergo observational data collection. No interventions will be made to patient care.

Interventions

Observational

All groups will undergo observational data collection. No interventions will be made to patient care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of SCFE
• Intend to receiving follow-up at participating centre
• Less than 18 years old at time of admission
• Adequate diagnostic information and radiographic imaging (for patients previously treated for SCFE)

Exclusion Criteria

• No definitive diagnosis of SCFE
• Do not intend to receive follow-up at a participating centre
• Greater than 18 years old at time of admission
• Prior treatment for SCFE not appropriately documented
• Known or suspected underlying conditions (e.g., cerebral palsy, spina bifida, or osteogenesis imperfecta)

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kishore Mulpuri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kishore Mulpuri, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kishore Mulpuri, FRCSC

Role: CONTACT

kmulpuri@cw.bc.ca

(604) 875-2054

Ashley L Munoz, BSc

Role: CONTACT

ashley.munoz@cw.bc.ca

(604) 875-2359

Facility Contacts

Emily K Schaeffer, PhD

Role: primary

emily.schaeffer@cw.bc.ca

6048752359

Ashley L Munoz, BSc

Role: backup

ashley.munoz@cw.bc.ca

6048752359

Other Identifiers

H15-03132

Identifier Type: -

Identifier Source: org_study_id