None listed
Conditions
Brief summary
The aim of this project is to examine the influence of different anatomical structures on knee kinematics in total knee arthroplasty (TKA), with focus on condylar movement over the tibia (pivot and rollback through flexion). The study will examine the hypotheses that tibial internal rotation in balanced Kinematic Alignment (KA) Cruciate Retaining (CR) Computer Assisted Surgery (CAS) is synonymous with a medial pivot. Patients will be prospectively recruited to undergo KA CR CAS TKA. Values obtained from CAS intraoperatively will be validated using additional values measured using an Orthosensor, Versasense device.
Interventions
Participants will prospectively undergo Kinematically Aligned (KA) Cruciate Retaining Computer Assisted Surgery (CAS). During surgery, the CAS (navigation) will be used to record a series of measurements or distances (mm) between anatomical landmarks of the patients native anatomy, and post surgery. The distances represent a 'laxity' assessment of each structure under observation in the knee. Intraoperative pressures and the direction of condylar movement will be measured during the time of p
Participants will prospectively undergo Kinematically Aligned (KA) Cruciate Retaining Computer Assisted Surgery (CAS). During surgery, the CAS (navigation) will be used to record a series of measurements or distances (mm) between anatomical landmarks of the patients native anatomy, and post surgery. The distances represent a 'laxity' assessment of each structure under observation in the knee. Intraoperative pressures and the direction of condylar movement will be measured during the time of prosthesis implantation by an Orthosensor device. Pre and post-operative radiographs will be taken and measured for comparison (and validation of) Intraoperative measures reported by CAS. Iliotibial tightness will be measured by the surgeon under anaesthesia, prior to surgically prepping the patient for surgery. It is anticipated that the additional ITB assessment and intraoperative measures using Navigation will add 10 minutes to the total surgical time; total surgical time is anticipated between one to two hours. Patients range of motion and radiographic investigations as well as Patient Report Outcomes Questionnaires will be recorded pre operative, 6months and 2 years postoperative as per surgeons standard of care. The validated PROMS selected for this study include Euroquol 5D (EQ-5D), Knee Arthroplasty Outcome Score (KOOS Jnr), Knee Society Score (KSS) and the Forgotten Joint Score (FJS). Should a patient choose to not enrol in the study, they too will undergo Kinematically Aligned (KA) Cruciate Retaining Computer Assisted Surgery as this is the surgeons standard of care surgical technique.
Sponsors
Orthopaedic Research Institute of Queensland
Eligibility
Sex/Gender
All
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
• The patient is a male or non-pregnant female. • The patient is aged between 45-90 years. • Patient suffers from severe osteoarthritis. • The patient has signed the study specific, HREC-approved, Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations. • The patient has an intact PCL and is a suitable candidate for a CR TKA (based on the Investigator’s clinical judgment).
Exclusion criteria
• The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis) • Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient’s capacity to consent to research and the ability to participate in it. • Prior injury / surgery to the PCL • The patient is medically unfit for TKA.
Outcome results
None listed