SCFE Longitudinal International Prospective Registry

Slipped Capital Femoral Epiphyses Clinical Trial

— SLIP  

Official title:

SLIP Registry - SCFE Longitudinal International Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117841
• Other study ID #: H15-03132
• Status: Recruiting
• Start date: May 30, 2018
• Est. completion date: May 2028

Study information

• Verified date: April 2024
• Source: University of British Columbia
• Contact: Kishore Mulpuri, FRCSC
• Phone: (604) 875-2054
• Email: kmulpuri[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• SCFE
• Slipped Capital Femoral Epiphyses

Intervention

Other:
• Observational
All groups will undergo observational data collection. No interventions will be made to patient care.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity		Until study completion in 2028
Primary	Comparison of the clinical, functional, and radiographic parameters related to SCFE in the context of treatment outcomes		Until study completion in 2028
Primary	Examination of the long-term outcome of prophylactically pinning the contralateral hip, specifically in regards to development of avascular necrosis		Until study completion in 2028
Primary	Determination of whether prophylactic fixation allows for preservation of hip morphology and function in the short and long term		Until study completion in 2028
Primary	Comparative analysis of surgical treatment outcomes, with particular regard to complications (avascular necrosis, femoroacetabular impingement (FAI), secondary surgeries)		Until study completion in 2028
Primary	Comparison of mild SCFE treatment with or without acute FAI treatment in regard to complication and short-term outcomes		Until study completion in 2028
Primary	Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE		Until study completion in 2028
Primary	Determination of the timeline for patients to return to full weight-bearing following treatment and to assess the level to which they return to activity		Until study completion in 2028