SCFE Longitudinal International Prospective Registry (SLIP)

• ClinicalTrials.gov Identifier: NCT04117841
• Recruitment Status: Recruiting
• First Posted: October 7, 2019
• Last Update Posted: October 7, 2019
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Kishore Mulpuri, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment
Slipped Capital Femoral Epiphyses; SCFE	Other: Observational

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 20 Years
• Official Title: SLIP Registry - SCFE Longitudinal International Prospective Registry
• Actual Study Start Date: May 30, 2018
• Estimated Primary Completion Date: May 2028
• Estimated Study Completion Date: May 2028

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: 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.

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)

Contacts and Locations

Contacts

Contact: Kishore Mulpuri, FRCSC; (604) 875-2054; kmulpuri@cw.bc.ca

Contact: Ashley L Munoz, BSc; (604) 875-2359; ashley.munoz@cw.bc.ca

Locations

Canada, British Columbia

British Columbia Children's Hospital; Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contact: Emily K Schaeffer, PhD 6048752359 emily.schaeffer@cw.bc.ca

Contact: Ashley L Munoz, BSc 6048752359 ashley.munoz@cw.bc.ca

Principal Investigator: Kishore Mulpuri, MSc

Sub-Investigator: Emily K Schaeffer, PhD

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: Kishore Mulpuri, FRCSC; Principal Investigator

More Information

• Responsible Party: Kishore Mulpuri, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT04117841
• Other Study ID Numbers: H15-03132
• First Posted: October 7, 2019
• Last Update Posted: October 7, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Slipped Capital Femoral Epiphyses; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Epiphyses, Slipped