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SCFE Longitudinal International Prospective Registry (SLIP Trial)

N/A
Recruiting
Led By Kishore Mulpuri, FRCSC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Slipped capital femoral epiphysis
  • Slipped Capital Femoral Epiphysis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 1380 Patients • NCT05004181
18%
Headache
12%
Nasal congestion
12%
Cough
12%
Fatigue
6%
Oropharyngeal pain
6%
Arthralgia
6%
Ageusia
6%
Nausea
6%
COVID-19
6%
Upper respiratory tract infection
6%
Diarrhoea
6%
Anosmia
6%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part A - Cohort 5: 1 Dose of 30 μg BNT162b2 (Original Vaccine)
Part B - Cohort 4: 1 Dose 30 μg BNT162b2 (B.1.617.2)
Part A - Cohort 2: 2 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part C - Cohort 7: 1 Dose of 30 μg BNT162b2 (B.1.1.529)
Part A - Cohort 1: 1 Dose of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part B - Cohort 6: 3 Doses of 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part A - Cohort 3: 1 Dose of 30 μg BNT162b2 (B.1.1.7)
Part A - Cohort 4: 1 Dose of 30 μg BNT162b2 (B.1.617.2)
Part B - Cohort 1: 1 Dose 30 μg BNT162b2 (B.1.1.7 + B.1.617.2)
Part C - Cohort 8: 1 Dose of 30 μg BNT162b2 (Original Vaccine)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm III: Prior treatment at outside centreExperimental Treatment1 Intervention
Patients who have received previous treatment at an outside center but are continuing treatment at a participating center will be placed into Arm III.
Group II: Arm II: Prior treatment at centreExperimental Treatment1 Intervention
Patients who have received previous treatment and will continue to receive treatment at the participating center will be placed into Arm II.
Group III: Arm I: Prospective from diagnosisExperimental Treatment1 Intervention
Patients have been enrolled and followed since diagnosis will be placed into Arm I.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,492,916 Total Patients Enrolled
Kishore Mulpuri, FRCSCPrincipal InvestigatorPrincipal Investigator
2 Previous Clinical Trials
5,514 Total Patients Enrolled
~655 spots leftby May 2028