Slipped Capital Femoral EpiphysesSLIPNCT04117841
SCFE Longitudinal International Prospective Registry
An observational study of Slipped Capital Femoral Epiphyses and SCFE, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Slipped Capital Femoral Epiphyses, SCFE
- What is being tested?
- Observational
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2018to May 2028
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Emily K Schaeffer, PhD, 6048752359, emily.schaeffer@cw.bc.ca
Ashley L Munoz, BSc, 6048752359, ashley.munoz@cw.bc.ca
About this study
Official title: 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.
- Conditions
- Slipped Capital Femoral Epiphyses, SCFE
- Being tested
- Observational
- Medical subject headings
- Slipped Capital Femoral Epiphyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
All groups will undergo observational data collection. No interventions will be made to patient care.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Prospective from diagnosis | Patients have been enrolled and followed since diagnosis will be placed into Arm I. Receives: 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. Receives: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity
Measured: Until study completion in 2028
Comparison of the clinical, functional, and radiographic parameters related to SCFE in the context of treatment outcomes
Measured: 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
Measured: Until study completion in 2028
Determination of whether prophylactic fixation allows for preservation of hip morphology and function in the short and long term
Measured: Until study completion in 2028
Comparative analysis of surgical treatment outcomes, with particular regard to complications (avascular necrosis, femoroacetabular impingement (FAI), secondary surgeries)
Measured: Until study completion in 2028
Comparison of mild SCFE treatment with or without acute FAI treatment in regard to complication and short-term outcomes
Measured: Until study completion in 2028
Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE
Measured: 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
Measured: Until study completion in 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start30 May 2018
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slipped Capital Femoral EpiphysesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishore Mulpuri, University of British Columbia
- Investigators
- Kishore Mulpuri, FRCSC, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117841
- Sponsor's protocol ID
- H15-03132
- Acronym
- SLIP
- Status last verified
- Apr 2024
- First submitted
- 2 Oct 2019
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLIP Registry - SCFE Longitudinal International Prospective Registry
- ClinicalTrials.gov ID
- NCT04117841
- Acronym / sponsor ID
- SLIP / H15-03132
- Conditions
- Slipped Capital Femoral Epiphyses, SCFE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I: Prospective from diagnosis | – | Other: ObservationalPatients have been enrolled and followed since diagnosis will be placed into Arm I. |
| Arm II: Prior treatment at centre | – | Other: ObservationalPatients who have received previous treatment and will continue to receive treatment at the participating center will be placed into Arm II. |
| Arm III: Prior treatment at outside centre | – | Other: ObservationalPatients who have received previous treatment at an outside center but are continuing treatment at a participating center will be placed into Arm III. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAll groups will undergo observational data collection. No interventions will be made to patient care. | Other | Arm I: Prospective from diagnosis, Arm II: Prior treatment at centre, Arm III: Prior treatment at outside centre |
Primary outcome
Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity
Time frame: 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
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
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
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
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
Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kishore Mulpuri, FRCSC principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Slipped Capital Femoral Epiphyses and SCFE, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kishore Mulpuri, FRCSC ((604) 875-2054, kmulpuri@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity (time frame: Until study completion in 2028). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.