Clinical trial NCT04117841: SCFE Longitudinal International Prospective Registry
Official title: SLIP Registry - SCFE Longitudinal International Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Slipped Capital Femoral Epiphyses
SCFE
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

Primary outcomes:
measure: Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity
timeFrame: Until study completion in 2028
measure: Comparison of the clinical, functional, and radiographic parameters related to SCFE in the context of treatment outcomes
timeFrame: Until study completion in 2028
measure: Examination of the long-term outcome of prophylactically pinning the contralateral hip, specifically in regards to development of avascular necrosis
timeFrame: Until study completion in 2028
measure: Determination of whether prophylactic fixation allows for preservation of hip morphology and function in the short and long term
timeFrame: Until study completion in 2028
measure: Comparative analysis of surgical treatment outcomes, with particular regard to complications (avascular necrosis, femoroacetabular impingement (FAI), secondary surgeries)
timeFrame: Until study completion in 2028
measure: Comparison of mild SCFE treatment with or without acute FAI treatment in regard to complication and short-term outcomes
timeFrame: Until study completion in 2028
measure: Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE
timeFrame: Until study completion in 2028
measure: 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
timeFrame: Until study completion in 2028
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: Principal Investigator
name: Kishore Mulpuri, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: