A pilot randomised controlled trial of occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis
- Conditions
- Musculoskeletal, All DiseasesMusculoskeletal DiseasesOther disorders of the musculoskeletal system
- Registration Number
- ISRCTN38381590
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the feasibility of a full scale RCT measured at the end of study with respect to:<br>1. Recruitment procedures measured by identification and response rates, recruitment rates and establishment of site specific procedures<br>2. Appropriateness, responsiveness and acceptability of outcome measures measured by analysis of any missing data and completion rates<br>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 Outcome Measures
Name Time Method 1. Pain<br>2. Functional activity <br>3. Societal participation <br>Measured at 4, 12 and 26 weeks and physical activity levels at 12 weeks (using accelerometry). <br><br>4. Record resource use <br>5. Adverse events<br>6. Clinical effect size <br>7. Directionality of the outcome measure questionnaires <br>Measured at the end of study<br><br>8. Health resource usage measured at 26 weeks<br>9. Pain<br>10. Functional activity<br>11. Societal participation<br>The above outcomes will be measured using patient administered questionaires at 4, 12 and 26 weeks<br><br>12. Physical activity using accelerometery will be measured at 12 weeks