Robotic and Orthosensor Assisted versus Manual (ROAM) TKR
Research type
Research Study
Full title
Robotic and Orthosensor Assisted versus Manual (ROAM) total knee replacement: A randomised controlled trial.
IRAS ID
247437
Contact name
David J Deehan
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Trust
ISRCTN Number
ISRCTN47889316
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Total knee replacement is one of the most commonly performed surgical procedures with over 100,000 carried out in the UK each year. It is well known that 10-20 % of patients undergoing knee replacement are dissatisfied with the outcome of their surgery. Patients complain of ongoing pain and instability, with a proportion needing further surgeries to revise the knee replacement.
There is no agreed explanation as to why there is such a large variation in satisfaction after knee replacement. It is acknowledged that the knee implant is not ideally positioned in up to 30% of standard knee replacement surgeries. We do not know how the positioning of the implant affects the patient’s outcome following surgery.
Robotic assisted surgery is a technique used by orthopaedic surgeons to ensure the implant is more accurately positioned during surgery. Although we know that this technique results in increased accuracy in positioning of the implant, we do not know if this would result in better outcomes for patients following their knee replacement.
We are carrying out a research study to see if a better outcome is achieved using robotic assisted surgery compared to standard surgery.We are recruiting 90 patients to participate in this study. Half will have their knee replacement performed using the standard technique; the other half will have their knee replacement performed using robotic assisted surgery to optimise the position of the knee implant. We will then compare the outcomes of the surgery to see if one group does better than the other.
We will collect information on participants recovery from surgery as well as their knee function, pain, satisfaction and walking up until 12 months after their knee replacement to see if one group does better than the other.
The research is funded by Stryker who make knee replacements and the MAKO robotic arm used in surgery.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0027
Date of REC Opinion
25 Feb 2019
REC opinion
Further Information Favourable Opinion