Musculoskeletal, All Diseases Musculoskeletal Diseases Other disorders of the musculoskeletal system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients accepted for surgery for primary THR following review in orthopaedic clinic 2. No previous lower limb joint replacement surgery 3. Osteoarthritis as the primary indication for surgery 4. No planned additional lower limb joint replacement surgery within 12 months 5. Unilateral surgery 6. Male & female participants 7. Lower Age Limit 55 years
Exclusion criteria
Exclusion criteria: 1. Patients with inflammatory arthritis 2. Patients whose existing comorbidities prevent them from participating in the proposed treatment intervention (such as stroke or amputation) 3. Patients who are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the feasibility of a full scale RCT measured at the end of study with respect to: 1. Recruitment procedures measured by identification and response rates, recruitment rates and establishment of site specific procedures 2. Appropriateness, responsiveness and acceptability of outcome measures measured by analysis of any missing data and completion rates 3. Fidelity of the intervention assessed by dropout rates, content of the intervention using an intervention log and acceptability of randomisation into the intervention/control. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain 2. Functional activity 3. Societal participation Measured at 4, 12 and 26 weeks and physical activity levels at 12 weeks (using accelerometry). 4. Record resource use 5. Adverse events 6. Clinical effect size 7. Directionality of the outcome measure questionnaires Measured at the end of study 8. Health resource usage measured at 26 weeks 9. Pain 10. Functional activity 11. Societal participation The above outcomes will be measured using patient administered questionaires at 4, 12 and 26 weeks 12. Physical activity using accelerometery will be measured at 12 weeks | — |
Countries
United Kingdom