Adults with osteoarthritis of the hip joint for which, in the opinion of the treating clinician, warrants a total hip replacement. Musculoskeletal Diseases Hip osteoarthritis
Conditions
Interventions
Conventional total hip replacement and robotic-assisted total hip replacement, using the Mako Robotic system (Stryker, USA)
Randomisation will be completed using a secure online web system and will b
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Osteoarthritis of the hip with pain, disability and radiological changes that, in the opinion of the treating clinician, warrants a total hip replacement 2. Conservative therapy has been unsuccessful, as judged by the treating clinician
Exclusion criteria
Exclusion criteria: 1. Osteoarthritis due to inflammatory arthropathy or intra-articular fracture, as judged by the treating clinician 2. Revision surgery or need for complex implants, or any other implant than a standard hybrid construct (Trident Exeter) or uncemented construct (Trident Accolade), as determined by the treating clinician. This includes nickel-free implants as well as those that require a long stem, augments, or custom made devices 3. Age < 18 years 4. Unfit for THR, or surgery is otherwise contra-indicated, for example, concurrent infection 5. Previous randomisation in the present trial, i.e. the other hip 6. Unable to take part or adhere to trial processes including prisoners or people unable to communicate or complete questionnaires in English, or people unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint awareness measured using the Forgotten Joint Score Hip-12 (FJS-12) at 12 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri-operative outcomes: 1. Mean pain intensity, using an 11-point numerical rating scale for "pain right now" and "pain since yesterday" on the morning of each of the first three days following surgery and at baseline 2. Estimated blood loss calculated using Brecher's formula, based on pre- and post-operative Haematocrit measurements from routinely collected clinical blood measurements, and volume, if any, of blood transfused 3. Opioid use to the end of day three measured using patient records 4. Hours from surgery to hospital discharge measured using patient records Outcomes collected at baseline, three and six months and one, two, five and ten years post-operation: 1. Overall hip pain and function measured using FJS-12 2. Overall hip pain and function measured using Oxford Hip Score 3. Health utility measured using EQ-5D-5L (also collected at 6 weeks) 4. Satisfaction with total hip replacement, measured using a five-point Likert scale 5. Resource use using patient questionnaires 6. Re-operations Process and Fidelity measures: 1. Time from skin incision to final dressing measured using patient records 2. Alignment measures at three months on a focused low-dose CT: rotation of femoral and acetabular components, leg length and offset compared to pre-operative plan Safety outcomes: 1. Adverse events relating to the operation, the anaesthetic or rehabilitation measured using patient records | — |
Countries
England, United Kingdom
Outcome results
None listed