None listed
Conditions
Brief summary
This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.
Interventions
Patients randomized to this group will undergo a TKA (total knee arthroplasty) to receive a Triathlon Total Knee System aligned according to Functional Alignment philosophy. This method of implant alignment is defined by a patient's native joint line as well as the soft tissue envelope. Triathlon Total Knee System components will be positioned relative to intra-operative soft tissue laxity assessment. The surgical intervention will be administered by a physician wherein the expected duration of
Patients randomized to this group will undergo a TKA (total knee arthroplasty) to receive a Triathlon Total Knee System aligned according to Functional Alignment philosophy. This method of implant alignment is defined by a patient's native joint line as well as the soft tissue envelope. Triathlon Total Knee System components will be positioned relative to intra-operative soft tissue laxity assessment. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours. A mobile application (KneeBalancer) will be used to assist surgeon decision making during the dynamic joint balancing surgical step.
Sponsors
Stryker Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are male or non-pregnant females requiring a primary total knee replacement for osteoarthritis and is indicated for robotic-assisted surgery 2. The patient has intact collateral ligaments 3. The patient is able to undergo CT scanning of the affected limb 4. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Exclusion criteria
1. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint 2. Patient has had a previous osteotomy around the knee 3. The patient is morbidly obese (BMI greater than 40) 4. The patient has a deformity which will require the use of stems, wedges, or augments in conjunction with the Triathlon Total Knee System 5. The patient has a varus/valgus deformity equal to or greater than 15 degrees 6. The patient has a fixed flexion deformity equal to or greater than 15 degrees 7. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device 8. The patient has a systemic or metabolic disorder leading to progressive bone deterioration 9. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements
Outcome results
None listed