Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT04117841

Conditions

Slipped Capital Femoral Epiphyses

SCFE

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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 ID

NCT04117841

Start date

May 30, 2018

Status verified date

Apr, 2024

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm I: Prospective from diagnosis

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

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.

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.

Interventions

Observational

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

Primary outcome measure

  • Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity [ Time Frame: Until study completion in 2028 ]
  • Comparison of the clinical, functional, and radiographic parameters related to SCFE in the context of treatment outcomes [ Time Frame: 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 [ Time Frame: Until study completion in 2028 ]
  • Determination of whether prophylactic fixation allows for preservation of hip morphology and function in the short and long term [ Time Frame: Until study completion in 2028 ]
  • Comparative analysis of surgical treatment outcomes, with particular regard to complications (avascular necrosis, femoroacetabular impingement (FAI), secondary surgeries) [ Time Frame: Until study completion in 2028 ]
  • Comparison of mild SCFE treatment with or without acute FAI treatment in regard to complication and short-term outcomes [ Time Frame: Until study completion in 2028 ]
  • Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE [ Time Frame: 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 [ Time Frame: Until study completion in 2028 ]

Central Contacts and Locations

Central contacts

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Principal Investigator:

Kishore Mulpuri, MSc

More Information

Sponsor

University of British Columbia

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-04-05.