Functional Independence, Knee Replacement, Total, Pain, Postoperative
Conditions
Brief summary
There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.
Interventions
PROCEDURETotal Knee Replacement
Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning.
Sponsors
North York General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* undergoing unilateral TKR for the treatment of osteoarthritis * between the age of 18 and 85 years of age * able to read, speak and understand English, have a telephone * are able to provide consent
Exclusion criteria
* enrolled in another study, are * undergoing revision surgery or bilateral surgery, and are * over the age of 85 years. Patients will also be excluded if they * have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Function | post-operatively 1 year | Oxford knee score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life following knee surgery | post-operatively at 2 years | EuroQol 5D index |
| Pain intensity and effectiveness of analgesics | Post-operatively at 6 weeks | Brief Pain Inventory-Short Form - Pain Severity Index |
| Satisfaction with knee surgery | Post-operatively at 6 weeks, 6 months, 1 year and 2 years | Forgotten Joint Score |
| Function | post-operatively at 6 weeks | Oxford knee score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Care Utilization | Post-operatively at 6 weeks | unanticipated visits to emergency department, primary care provide, surgeon due to knee surgery |
Countries
Canada
Outcome results
None listed