SCFE Longitudinal International Prospective Registry (SLIP)

April 3, 2024 updated by: Kishore Mulpuri, University of British Columbia

SLIP Registry - 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kishore Mulpuri, MSc
        • Sub-Investigator:
          • Emily K Schaeffer, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 18 years (Child, Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Arm I: Prospective from diagnosis
Patients have been enrolled and followed since diagnosis will be placed into Arm I.
Other: Observational
All groups will undergo observational data collection. No interventions will be made to patient care.
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
All groups will undergo observational data collection. No interventions will be made to patient care.
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
All groups will undergo observational data collection. No interventions will be made to patient care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity
Time Frame: Until study completion in 2028
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
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
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
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
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
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
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
Until study completion in 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kishore Mulpuri, FRCSC, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H15-03132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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