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NCT Number: NCT04117841

SCFE Longitudinal International Prospective Registry

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.

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Key information

Conditions

Slipped Capital Femoral Epiphyses Bone Diseases Bone Diseases, Developmental Epiphyses, Slipped Musculoskeletal Diseases Osteochondrodysplasias SCFE

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location status: Recruiting

Location contact

Ashley L Munoz, BSc

CONTACT

[email protected]

6048752359

Emily K Schaeffer, PhD

CONTACT

[email protected]

6048752359

Emily K Schaeffer, PhD

SUB_INVESTIGATOR

Kishore Mulpuri, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observational

Other

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

Primary outcomes

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

    Time frame: Until study completion in 2028

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

    Time frame: Until study completion in 2028

  3. 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

  4. 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

  5. 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

  6. 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

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

    Time frame: Until study completion in 2028

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley L Munoz, BSc

CONTACT

[email protected]

(604) 875-2359

Kishore Mulpuri, FRCSC

CONTACT

[email protected]

(604) 875-2054

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

SLIP Registry - SCFE Longitudinal International Prospective Registry

Acronym: SLIP

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Oct 7, 2019
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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