NCT04117841 SCFE Longitudinal International Prospective Registry
| NCT ID | NCT04117841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Slipped Capital Femoral Epiphyses |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2018-05-30 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2018-05-30 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Kishore Mulpuri, FRCSC
PRINCIPAL INVESTIGATOR
Principal Investigator
Frequently Asked Questions
Who can join the NCT04117841 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Slipped Capital Femoral Epiphyses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04117841 currently recruiting?
Yes, NCT04117841 is actively recruiting participants. Contact the research team at kmulpuri@cw.bc.ca for enrollment information.
Where is the NCT04117841 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT04117841 clinical trial?
NCT04117841 is sponsored by University of British Columbia. The principal investigator is Kishore Mulpuri, FRCSC at Principal Investigator. The trial plans to enroll 2,000 participants.