A comparison between robotic and orthosensor-assisted total knee replacement and standard total knee replacement surgery

INTERVENTION: A randomised controlled trial will be conducted to compare the outcomes of patients undergoing a conventional manual knee replacement to those undergoing TKR using robotic assisted surgery and the Orthosensor to optimise alignment and balance the knee joint respectively and assess the associated cost economics of such technology. The null hypothesis is that an optimally aligned and balanced TKR carried out with robotic assisted surgery and the use of the Orthosensor does not improve patient outcomes when compared to a TKR carried out manually. Informed Consent Written and verbal versions of the Participant Information Sheet and Informed Consent Form will be presented to the participants by the research team. These will explain the exact nature of the study, the implications and constraints of the protocol and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The participant will be encouraged to take the study information home and have the opportunity to question the Investigator, their GP or other independent parties to decide whether they will participate in the study. Participants who decide to take part will be invited to an additional research visit to provide written informed consent. The person who obtained the consent will be a suitably qualified and experienced member of the research team, and have been authorised to do so by the Chief/Principal Investigator. Copies of the signed Informed Consent will be given to the participants as well as filed in the medical no CONDITION: Arthrosis of knee ; Musculoskeletal Diseases ; Arthrosis of knee PRIMARY OUTCOME: Early functional outcome (measured by the WOMAC) from baseline to 6 months following TKR SECONDARY OUTCOME: ; 1. Knee function in activities of daily living measured by the Oxford Knee Score (OKS) from baseline to 8 weeks, 6 and 12 months; 2. Joint awareness measured by the Forgotten Joint Score (FJS) from baseline to 8 weeks, 6 and 12 months; 3. Satisfaction after total knee replacement measured using a validated outcome measure at 8 weeks, 6 and 12 months; 4. Pain, stiffness and functional ability measured using components of the WOMAC at 8 weeks, 6 and 12 months and function at 8 weeks and 12 months; 5. Health‐related quality of life measured using the EQ‐5D‐3L at baseline, 8 weeks, 6 and 12 months; 6. Cost‐effectiveness of the two interventions from a UK NHS perspective measured using a health service resource use questionnaire will be completed by the patient at the 8 weeks, 6 and 12 month post‐surgical research assessment. Inpatient and surgical data will be collected on the case report forms (CRF’s) and complications will be recorded at each visit. The tariffs associated with surgery, in‐patient stay, follow up visits and any treatment for complications will be retrieved from hospital finance records at the end of the follow up period; 7. Gait patterns and balance (centre of pressure excursion) will be measured using a TekScan instrumented walkway over which patients walk and stand. Activity levels will be monitored in a sub‐set of patients using ActivPal activity monitors. Gait/balance/activity will be monitored pre‐surgery and at 12 months post‐surgery.; INCLUSION CRITERIA: 1. Listed for elective primary TKR for end stage osteoarthritis under the care of the two participating surgeons 2. Male or female, age 45 – 85 at the time of listing for surgery 3. Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)