A comparison of standard versus robotic total knee replacement

Phase 3

• Conditions: 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]

• Registration Number: ISRCTN27624068
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37295832/ (added 12/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-08
• Last Update Posted: 27 February 2024
• Study Completion: 2032-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 339

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 06/01/2023:<br>Patient awareness of their joint measured using Forgotten Joint Score (FJS) questionnaire at 12 months post-randomisation<br><br><br>Previous primary outcome measure:<br>Patient awareness of their joint measured using Forgotten Joint Score (FJS) questionnaire at baseline, 3, 6, 12 months, 2, 5 and 10 years