Osteoarthritis of the knee with pain, disability and changes on standard of care clinical images (x-rays or MRI according to normal clinical practice) that, in the opinion of the treating clinician, warrants total knee replacement (TKR) Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
RACER is a multi-centre, patient-assessor blinded, pragmatic randomised controlled trial to assess the clinical and cost-effectiveness of robotic total knee replacement (TKR) compared to conventional
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Osteoarthritis of the knee with pain, disability and changes on standard of care clinical images (x-rays or MRI according to normal clinical practice) that, in the opinion of the treating clinician, warrants total knee replacement (TKR) 2. Conservative therapy has been unsuccessful, as judged by the treating clinician
Exclusion criteria
Exclusion criteria: 1. Osteoarthritis secondary to inflammatory arthropathy or intra-articular fracture as determined by the treating clinician 2. Revision surgery or need for complex implants, or any other implant than a standard Triathlon total knee replacement (TKR), 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 TKR, or surgery is otherwise contraindicated (for example, concurrent infection) 5. Previous randomisation in the present trial (i.e. other knee) 6. Unable to take part in 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 |
|---|---|
| Current primary outcome measure as of 06/01/2023: Patient awareness of their joint measured using Forgotten Joint Score (FJS) questionnaire at 12 months post-randomisation Previous primary outcome measure: Patient awareness of their joint measured using Forgotten Joint Score (FJS) questionnaire at baseline, 3, 6, 12 months, 2, 5 and 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 06/01/2023: In-hospital outcomes: 1. Mean pain intensity measured using an 11-point numerical rating scale (NRS) questionnaire for ‘pain right now’ and ‘pain since yesterday’ on the morning of each of the first 3 days after surgery 2. In-patient estimated blood loss calculated using Brecher’s formula, based on pre- and post-operative Haematocrit measurements obtained from reviewing patients notes post-discharge 3. In-patient opioid use obtained from patient’s medical notes (total morphine equivalent, using conversion methods established in I-WOTCH, NIHR HTA 14/224/04) to the end of day 3 4. Hours from surgery to hospital discharge obtained from patient’s medical notes post-discharge 5. Pain over the past 24 hours, when the operated knee is at rest and when it is moved, collected as above on the first three days. Postoperative outcomes: 1. Overall knee function measured using the FJS at baseline, 3, 6, 12 months, 2, 5 and 10 years 2. Outcomes of knee osteoarthritis surgery measured using the Oxford Knee Score (OKS) questionnaire at baseline, 3, 6, 12 months, 2, 5 and 10 years 3. Levels of activity and (social) participation measured using the Oxford Knee Score Activity and Participation Questionnaire (OKS – APQ) at baseline, 3, 6, 12 months, 2, 5 and 10 years 4. Generic health status measured using the EQ5D-5L questionnaire at baseline, 6 weeks, 3, 6, 12 months, 2, 5 and 10 years 5. Pain over the last week measured using the three-item PROMIS Pain Intensity Scale questionnaire at baseline, 3, 6, 12 months, 2, 5 and 10 years 6. Satisfaction with the knee replacement measured using a five-point Likert scale questionnaire at 3, 6, 12 months, 2, 5 and 10 years 7. Activity limitations, symptoms, emotions, and overall quality of life-related to the painful condition assessed using a Participant Global Impression of Change questionnaire – a seven-point Likert scale – at 3, 6, 12 months, 2, 5 and 10 years 8. Number of re-operations | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed