Osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
This study is a multi-centre, three-group, superiority randomised controlled trial with patient-level randomisation, internal pilot, embedded qualitative research and health economic analysis in patie
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Between 18 and 69 years of age (inclusive) at the time of screening 2. Undergoing primary elective THR due to osteoarthritis (patients may also have other indications for THR in addition to osteoarthritis)
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 11/05/2026: 1. Receiving primary THR for reasons other than osteoarthritis (e.g., rheumatoid arthritis, etc.) 2. Patients requiring custom-made implants 3. Non-elective patients 4. Patients who lack capacity 5. Patients paying privately for their surgery 6. Prisoner 7. Patients undergoing 2-stage THR 8. Patients who have previously been randomised to the HIPPY trial _____ Previous key exclusion criteria as of 21/10/2025: 1. Not willing to consent 2. Receiving primary THR exclusively for reasons other than osteoarthritis (e.g., rheumatoid arthritis, etc.), 3. Patients requiring custom-made implants, 4. Non-elective patients 5. Patients who lack capacity 6. Patients paying privately for their surgery (including patients using health insurance) 7. Prisoner 8. Patients who have previously been randomised to the HIPPY trial _____ Previous key exclusion criteria: 1. Not willing to consent 2. Receiving primary THR exclusively for reasons other than osteoarthritis (e.g., rheumatoid arthritis, etc.), 3. Patients with dysplastic osteoarthritis requiring custom-made uncemented implants, 4. Non-elective patients 5. Patients who lack capacity 6. Patients paying privately for their surgery (including patients using health insurance) 7. Prisoner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revision surgery measured using routine data from linked patient databases and/or data reported by participants in questionnaires at 10 years post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost-effectiveness of the three implant types at 10 years and for the remainder of the patients’ lives. In secondary analyses, cost-effectiveness will also be estimated for implants characterized by fixation and bearing surface. 2. Yearly revision rates (descriptive) measured using data collected from patients on annual questionnaires to triangulate with or supplement our primary outcome data collection methods until the last follow-up of the trial. After the primary outcome at 10 years, further funding will be sought to collect revision rates using linkage to routine data at 5-year intervals. 3. Health-related quality of life and quality-adjusted life years (QALYs) measured using patient-completed EQ-5D-5L at baseline, 6- and 12-months post-randomisation and annually thereafter. The trial questionnaires will be complemented by linkage with the national PROMS database for EQ-5D-3L at baseline and 6 months after primary and revision surgeries for trial patients 4. Pain measured using the Hip disability and osteoarthritis outcome score (HOOS-12) pain scale at baseline, 6- and 12-months post-randomisation 5. Activity measured using the HOOS-12 activity limitations daily living score at baseline, 6- and 12-months post-randomisation 6. Function measured using the Oxford hip score (OHS) collected from linkage with the national PROMS database at baseline and 6 months after primary and revision surgeries for trial patients. 7. Capability measured using the ICECAP-A at baseline, 6- and 12-months post-randomisation 8. Return-to-work and usual activities measured using a bespoke questionnaire about absenteeism and presenteeism at 6-months post-randomisation, and the Work Productivity and Activity Impairment (WPAI) questionnaire at 12 months post-randomisation 9. Resource use (initial patient stay) measured using data collected from patient medical records, linked data and participant questionnaires at 6- and 12-months post-randomisation | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactSamantha Abbs
Outcome results
None listed