Hip surgery Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with osteoarthritis of the hip 2. Patients suitable for a cementless acetabular component 3. Patients over the age of 18 years 4. Patients of any Body Mass Index (BMI) 5. Patients willing and able to provide informed consent in English
Exclusion criteria
Exclusion criteria: 1. Patients with active systemic or local infection that would preclude standard THR surgery 2. Patients undergoing bilateral THR in same operative episode 3. Patients unable to give informed consent 4. Patients unable or unwilling to take part in the trial process, including patients unable to undertake activity monitoring data collection or complete the PROMS questionnaires in English (English is the only common translation available in official translations of all six PROMS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, sleep, nausea and feeling unwell, and mobility, are measured using the Oxford Arthroplasty Early Recovery Score (OARS) at 6 weeks post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle damage and inflammation are measured using serum creatinine kinase (CK) and C-reactive protein (CRP) blood biomarkers at the pre-operative assessment, day 0/1, and at 6 weeks post-operatively. 2. Walking and sleep quality are measured using activity monitors to collect 2 weeks of continuous data at the pre-operative assessment, and 6 weeks, 6 months, and 12 months post-operatively. 3. Patient perspective on their treatment is measured using the Oxford Arthroplasty Early Change Score (OACS) at 6 weeks post-operatively. 4. Pain and function are measured using the Oxford Hip Score (OHS) at the pre-operative assessment, and 6 weeks, 6 months, and 12 months, post-operatively. 5. Function is measured using the Lower Extremity Functional Scale (LEFS) at the pre-operative assessment, and 6 weeks, 6 months, and 12 months post-operatively. 6. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression are measured using the EQ-5D-5L questionnaire at the pre-operative assessment, and 6 weeks, 6 months, and 12 months post-operatively. 7. Patient satisfaction is measured using the Self-Administered Patient Satisfaction Scale (SAPS) at 6 weeks, 6 months, and 12 months post-operatively. 8. Clinical outcomes: ‘duration of surgery’, ‘blood loss’, and ‘length of hospital stay’ are recorded during and immediately after surgery. 9. Additional analgesia use (not included as part of standard care) is recorded during the first 6 weeks post-operatively. 10. The safety of approaches is measured by recording adverse events from the day of surgery until 12 months post-operatively. | — |
Countries
England, United Kingdom