Perthes’ disease Musculoskeletal Diseases
Conditions
Interventions
The proposed project is a two-phase trial.
Phase 1 (internal pilot) will take place at a minimum of 15 centres over a 12-month period and will confirm the expected rate of recruitment and data collec
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Radiographic evidence of Perthes’ disease 2. Radiographs demonstrate that the disease is in the initial, sclerotic or fragmentation stage 3. Aged 5 to 12 years inclusive 4. Willing and able to give informed assent/consent
Exclusion criteria
Exclusion criteria: 1. There is evidence that the patient and/or parent would be unable to adhere to the study procedures or complete follow-up, such as insufficient comprehension 2. Child has undergone prior containment surgery on the affected hip (i.e. the hip to be randomised) 3. The child has previously been enrolled into the OP Non-STOP Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Function is measured using the PROMIS Proxy Mobility Score at 36 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Function is measured using the PROMIS Proxy Mobility Score at Baseline, 3, 6, 9, 12, 18, 24, 30 and 36 months post-randomisation 2. Pain is measured using the Wong-Baker FACES pain rating scale at Baseline, 3, 6, 12, 18, 24, 30 and 36months post-randomisation 3. Quality of life is measured using the CHU-9D questionnaire at 3, 6, 9, 12, 18, 24, 30 and 36 months post-randomisation 4. Impact on family life is measured using the PROMIS Proxy Family Relationships Score at 3, 6, 9, 12, 18, 24, 30 and 36 months post-randomisation 5. Educational Participation is measured using a bespoke 'days of missed educational attendance' questionnaire at 3, 6, 9, 12, 18, 24, 30 and 36 months post-randomisation 6. Complication rate measured using a bespoke complications questionnaire at 6, 12, 18, and 36 months post-randomisation 7. Cost-effectiveness from the UK NHS and Personal Social Services perspective is measured using Healthcare and Personal Resource use, absence from work, purchased childcare and CHU-9D questionnaires at baseline (CHU-9D only), 6, 9, 12, 18, 24, 30 and 36 months post-randomisation 8. The degree of residual deformity is measured from routinely collected images of the hip or pelvis at 30-36 months post-randomisation | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactDaniel Perry
Outcome results
None listed