Robotic assisted vs instrumented total knee replacement (TKR): a single-blind randomised controlled clinical trial.

INTERVENTION: In this single‐site, multi‐surgeon trial, 100 people (50 in each arm) with knee osteoarthritis will be randomized to undergo unilateral total knee replacement (TKR) surgery at Nepean Private Hospital (NPH) either with the assistance of a robotic arm (ROSA) (TKR‐ROSA) or with the conventional method of using standard company manufactured instruments (jigs) (TKR‐Jigs). Nepean Private Hospital is a high‐volume arthroplasty centre and participating surgeons are experienced with subspeciality knee arthroplasty training and at least eight years of post‐fellowship experience. Surgeons participating in this study already routinely use TKR ROSA. The procedure time for TKR jigs and TKR ROSA are no different, 60‐120mins. CONDITION: Musculoskeletal ‐ Osteoarthritis Surgery ‐ Surgical techniques Total knee replacement (TKR) surgery ; ; Total knee replacement (TKR) surgery PRIMARY OUTCOME: The primary aim is to determine if TKR‐ROSA compared to TKR‐Jigs yields at least a minimal important difference of 5 points, assessed using the oxford Knee Score (OKS).[1‐year post‐surgery] We will use the approved Nepean Blue Mountain local Health District Serious Adverse Event (SAE) Form to report any complication. This form is readily available (SAE form NBMLHD Research Ethics) and approved be the ethics to be used for this study,; All safety events will be reported at quarterly Nepean Private Hospital orthopaedic department mortality and morbidity meetings as well .; ; We will also report any adverse events particularly related to the use of the ROSA robotic arm, which include:; Pin site fracture will be assessed using low‐dose CT scan; ; Robotic arm failure (technical errors) requiring conversion to conventional jig‐ guided surgery. Although, no known technical failure has been reported with ROSA. Data regarding robotic arm failure requiring conversion to conventional jig‐guided surgery will be properly documented and extracted from the surgeon operation notes .; ; Contamination of surgical drapes related to the use of the ROSA robotic arm assessed by SWAB for microscopy and culture.[1‐year post‐surgery] INCLUSION CRITERIA: Population The study population will include individuals aged greater than or equal to 18 years presenting to participating surgeons for TKR due to knee osteoarthritis (OA). Inclusion criteria • Primary TKR surgery secondary to OA • Able to provide informed consent in English SECONDARY OUTCOME: Change in end‐range knee flexion and extension upon hospital discharge assessed with photography measurement.[ 6, 26 and 52 weeks and at 5 years post surgery.] Change in Knee injury and Osteoarthritis Outcome Score (KOOS) 12‐item short form and patellofemoral subscales upon discharge from hospital. ; [6, 26 and 52 weeks and at 5 years post‐surgery.] Change in restoration of neutral mechanical limb alignment and component orientation assessed with low‐dose CT scan measurement (Composite) .[6‐months post‐surgery.] Minimal important difference in OKSs.[6weeks, and 26weeks and 5yrs post‐surgery.] Patient reported satisfaction with TKR and global improvement in outcome assessed using United Kingdom Patient Reported Outcome Measures UK PROM program (Composite). [6, 26 and 52 weeks and at 5 years post‐surgery .. ]