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Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.
James Griffin1,2, Edward T Davis3, Helen Parsons4,2
1Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK James.Griffin@warwick.ac.uk.
BMJ Open
|June 9, 2023
Summary
This study evaluates robotic-assisted versus conventional total knee replacement (TKR) to determine if robotic systems improve patient outcomes and are cost-effective. Results will guide clinical practice and healthcare system decisions regarding this technology.
Area of Science:
- Orthopedic surgery
- Medical technology evaluation
- Health economics
Background:
- Robotic-assisted knee replacement systems are increasingly used globally.
- Evidence for their clinical and cost-effectiveness in total knee replacement (TKR) is limited.
- Conventional TKR may offer comparable or superior outcomes and cost-efficiency.
Purpose of the Study:
- To compare the clinical and cost-effectiveness of robotic-assisted TKR versus conventional TKR.
- To provide robust evidence on the benefits of robotic-assisted knee replacement for patients.
- To assess the economic value of robotic systems in TKR for healthcare systems.
Main Methods:
- A multicentre, participant-assessor blinded, randomised controlled trial (RCT).
- 332 participants randomized (1:1) to robotic-assisted or conventional TKR.
- Primary outcome: Forgotten Joint Score at 12 months; intention-to-treat analysis.
Main Results:
- Primary outcome data collection ongoing.
- Secondary data on learning effects of robotic systems will be collected.
- Study aims to provide high-quality evidence on comparative effectiveness and cost.
Conclusions:
- The study will determine if robotic-assisted TKR offers superior clinical outcomes and cost-effectiveness compared to conventional methods.
- Findings will inform adoption of robotic technology in knee replacement surgery.
- Results will guide healthcare providers and policymakers on optimal TKR strategies.
