SCFE Longitudinal International Prospective Registry

NCT04117841 | Recruiting

• 1 other identifier: H15-03132
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity

  Until study completion in 2028

• Comparison of the clinical, functional, and radiographic parameters related to SCFE in the context of treatment outcomes

  Until study completion in 2028

• 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

• Determination of whether prophylactic fixation allows for preservation of hip morphology and function in the short and long term

  Until study completion in 2028

• Comparative analysis of surgical treatment outcomes, with particular regard to complications (avascular necrosis, femoroacetabular impingement (FAI), secondary surgeries)

  Until study completion in 2028

• Comparison of mild SCFE treatment with or without acute FAI treatment in regard to complication and short-term outcomes

  Until study completion in 2028

• Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE

  Until study completion in 2028

• 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

Study Arms (3)

Arm I: Prospective from diagnosis

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

Other: Observational

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.

Other: Observational

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.

Other: Observational

Interventions

Observational OTHER

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

Arm I: Prospective from diagnosis; Arm II: Prior treatment at centre; Arm III: Prior treatment at outside centre

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who have been diagnosed with SCFE and receive follow-up at a participating centre will be included in the registry. Patients will be enrolled during one of their routine clinic appointments at one of the participating centers.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Slipped Capital Femoral Epiphyses

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Epiphyses, Slipped

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Kishore Mulpuri, FRCSC

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kishore Mulpuri, FRCSC

CONTACT

(604) 875-2054; kmulpuri@cw.bc.ca

Ashley L Munoz, BSc

CONTACT

(604) 875-2359; ashley.munoz@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 7, 2019
• Study Start: May 30, 2018
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)