None listed
Conditions
Brief summary
Total knee arthroplasty (TKA) is a highly successful surgical treatment for patients with end-stage osteoarthritis. Unicompartmental knee arthroplasty (UKA) is an alternative option if patients have single-compartment isolated osteoarthritis. UKA is less invasive and can have benefits over TKA, including lower rates of post-operative mortality and readmissions, shorter length of stay, increased range of motion (ROM), and physiologically more normal gait. Despite potential benefits, there is low usage associated with a higher technical demand and an increased risk of revision surgery. Therefore, technology or techniques that could improve outcomes and reduce the risk of UKA revision are important. The primary objective of this study is to compare surgical and post-surgical outcomes of robotic (CORI system) vs. conventional (non-robotic) UKA in the early post-operative period using wearable Sensor-Based Inertial Measurement Unit (IMU) technology and PROMs.
Interventions
This is a prospective, non-randomised, non-blinded, longitudinal study of early clinical outcomes of patients with osteoarthritis of the knee who are eligible for unicompartmental (partial) knee arthroplasty (UKA). The most suitable intervention for the patient will be chosen at physician discretion.
Participants in the intervention group will undergo UKA procedure with the robotic REAL INTELLIGENCE™ CORI™ unit performed by consultant orthopaedic surgeons. The CORI unit will be used in surgery
This is a prospective, non-randomised, non-blinded, longitudinal study of early clinical outcomes of patients with osteoarthritis of the knee who are eligible for unicompartmental (partial) knee arthroplasty (UKA). The most suitable intervention for the patient will be chosen at physician discretion. Participants in the intervention group will undergo UKA procedure with the robotic REAL INTELLIGENCE™ CORI™ unit performed by consultant orthopaedic surgeons. The CORI unit will be used in surgery and involves the use of bony landmarks and computer navigation trackers to more accurately work out alignment of bony cuts aiding better positioning of the implant over not using it. The approximate duration of a UKA procedure is 90 minutes. The robotic navigation technique is expected to add approximately 10 minutes to the procedure, therefore the total time of the operation will be approximately 100 minutes.
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient is deemed appropriate for a unicompartmental knee replacement. • Patients are deemed skeletally mature (>18 years of age) • The patient has a primary diagnosis of osteoarthritis (OA), avascular necrosis, functional deformity or fractures that are unmanageable using other techniques. • The patient has intact collateral ligaments. • The patient has signed the study specific, ethics-approved, Informed Consent document. • The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion criteria
• The patient is receiving UKA as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA (e.g. stems, augments, osteotomy, or custom made devices). • The patient is undergoing simultaneous bilateral knee arthroplasty. • The patient has been diagnosed as having an active infection. • The patient is morbidly obese (BMI greater than or equal to 41). • Patient, in the opinion of the Investigators, has a cognitive, emotional, neurological or neuromuscular condition that would pre-empt their ability or willingness to participate in the study, or may interfere with UKA survival or outcome. • Patient does not meet the indication, or is contraindicated, for UKA according to the knee system’s Instructions for Use (IFU). • Patient is pregnant or breastfeeding at time of surgery.
Outcome results
None listed