ClinicalTrials.gg
RecruitingNCT04117841SLIPUpdated Apr 5, 2024

SCFE Longitudinal International Prospective Registry

An observational study in Slipped Capital Femoral Epiphyses and SCFE, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by University of British Columbia · Observational

From the registry’s dates

  • Started May 2018; still recruiting 8 years 5 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Slipped Capital Femoral Epiphyses
  • SCFE
03

In context

Slipped Capital Femoral Epiphyses

19 studies on the registry are indexed under Slipped Capital Femoral Epiphyses; 2 are open to participants now.

Browse Slipped Capital Femoral Epiphyses studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,340 studies on the registry; 260 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherObservational

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2018 (actual). Primary completion is estimated for May 2028, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2019
First posted
Oct 7, 2019
StartActual
May 30, 2018
Primary completionEst.
May 2028
CompletionEst.
May 2028
Last update
Apr 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04117841
Responsible party
Kishore Mulpuri (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Oct 7, 2019
Start date
May 30, 2018
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Apr 5, 2024

Study contacts

Kishore Mulpuri, FRCSC
Contact
kmulpuri@cw.bc.ca
(604) 875-2054
Ashley L Munoz, BSc
Contact
ashley.munoz@cw.bc.ca
(604) 875-2359
Kishore Mulpuri, FRCSC
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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