Slipped capital femoral epiphysis (SCFE) Musculoskeletal Diseases
Conditions
Interventions
The proposed project is a two-phase trial.
Phase 1 (internal pilot) will take place at a minimum of 20 centres and will confirm the expected rate of recruitment and data collection procedures. It wil
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
8 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Aged 8 to 15 years old inclusive 2. There is radiographic evidence of a SCFE* 3. The child is able to walk with or without the use of crutches or walking aids (i.e., the SCFE fulfils the ‘Loder’ definition of ‘Stable’) 4. The magnitude of the SCFE is severe; such that the treating clinician believes that it will cause significant femoroacetabular impingement *NB: Patients with opposite SCFE that is concurrent (new) or fixed previously (old) can be included (as long as they have not previously been included in the BigBOSS study). If the opposite-sided hip is concurrent, the most severe hip will be considered the hip of interest.
Exclusion criteria
Exclusion criteria: 1. There is evidence that the patient and/or parent/guardian would be unable to adhere to trial procedures or complete follow-up 2. The patient has previously been enrolled into the Big Boss Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Function measured using the PROMIS Mobility Tool at 24 months post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Function measured using the PROMIS Mobility Tool at baseline, 8 weeks, 3, 6 and 12 months post-randomisation 2. Pain measured using the Wong-Baker FACES pain rating scale at baseline, 8 weeks, 3, 6, 12 and 24 months post-randomisation 3. Quality of life measured using EQ-5D-Y at baseline, 8 weeks, 3, 6, 12 and 24 months post-randomisation 4. Satisfaction with care is measured using a satisfaction score at 8 weeks and 24 months post-randomisation 5. Educational participation is measured using a bespoke days of missed educational attendance questionnaire at baseline, 8 weeks, 3, 6, 12 and 24 months post-randomisation 6. Cost-effectiveness of treatments measured using Healthcare and Personal Resource use, absence from work, purchased childcare and EQ-5D-Y questionnaires at baseline, 8 weeks, 3, 6, 12 and 24 months post-randomisation 7. Complication rate measured using a bespoke complications questionnaire at 8 weeks, 12 and 24 months post-randomisation | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed