Total versus Robotic Assisted Unicompartmental Knee Replacement
Research type
Research Study
Full title
Total versus Robotic Assisted unicompartmental KneE Replacement (TRAKER) for medial compartment osteoarthritis
IRAS ID
263001
Contact name
Nicholas Clement
Contact email
Sponsor organisation
NHS Lothian
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Unicompartmental knee arthroplasty (UKA) is an accepted management option for patients with end stage isolated medial compartmental joint disease. The potential advantages UKA are accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics when compared to total knee arthroplasty (TKA). However, UKA is not universally employed by all surgeons as there is an associated higher revision rate (failure) when compared to TKA (12% vs 3% at 10years). The higher revision rate of UKA is thought to be primarily due to component malpositioning and limb malalignment. Robotic assisted (r)UKA enables the surgeon to position the prosthesis up to four times more accurately when compared to manual UKA and is associated with improved early functional outcome. A recent multi-centre review of 432 rUKA demonstrated the 6years survivorship to be 97%. Therefore, the accepted functional benefits and lower complication rates of UKA could potentially be enjoyed by the patient without the increased risk of early revision when compared to the current gold standard manual TKA.
The proposed randomised controlled trial aims to compare the early functional differences of rUKA with the current gold standard of TKA for patients with end stage medial compartment osteoarthritis. Patients will be recruited from a single centre where 800 TKA are performed annually. It is estimated that approximately 300 patients will meet the inclusion criteria and that recruitment will take approximately one year. Patients would need to attend an additional preoperative research clinic and for those undergoing rUKA they would need to have a preoperative CT scan. Postoperatviely patients would need to attend an additional research clinic at 6months.
Stryker (the company that manufacture the robot) have agreed to partially sponsor the study and will supply the robot and intraoperative consumables free of charge and will pay for the preoperative CT scan for those undergoing rUKA.
REC name
Scotland B REC
REC reference
20/SS/0011
Date of REC Opinion
3 Mar 2020
REC opinion
Further Information Favourable Opinion