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The study was prematurely terminated due to a long pause in study activities and significant missing participant data.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Adjusted Mechanical Alignment | Active Comparator | Usual care:
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| Robotic Assisted Adjusted Mechanical Alignment | Experimental |
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| Robotic Assisted Kinematic Alignment: (Joint line restoration) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Function | Oxford knee score | post-operatively 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life following knee surgery | EuroQol 5D index | post-operatively at 2 years |
| Quality of Life following knee surgery | EuroQol 5D index |
| Measure | Description | Time Frame |
|---|---|---|
| Health Care Utilization | unanticipated visits to emergency department, primary care provide, surgeon due to knee surgery | Post-operatively at 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Mastrogiacomo, PhD | North York General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North York General Hospital | Toronto | Ontario | M2K 1E1 | Canada |
Knowledge translation will occur utilizing a variety of mechanisms. The results of this study will be disseminated at the Canadian Orthopaedic Association conference. They will also be published in an high impact journal. At the provincial level, the data from this study will be shared with Health Quality Ontario, as a requirement of the bundled care program. At the local level, the investigators will disseminate the results of this study as aggregate data at North York General Hospital with to the health care practitioners and administrators involved with caring for the arthroplasty patient population.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Experimental |
-- Midline incision, no tourniquet, medial parapatellar arthrotomy, resect anterior osteophytes
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| post-operatively at 6 weeks |
| Quality of Life following knee surgery | EuroQol 5D index | post-operatively at 6 months |
| Quality of Life following knee surgery | EuroQol 5D index | post-operatively at 1 year |
| Pain intensity and effectiveness of analgesics | Brief Pain Inventory-Short Form - Pain Severity Index | Post-operatively at 6 weeks |
| Pain intensity and effectiveness of analgesics | Brief Pain Inventory-Short Form - Pain Severity Index | Post-operatively at 6 months |
| Pain intensity and effectiveness of analgesics | Brief Pain Inventory-Short Form - Pain Severity Index | Post-operatively at 1 year |
| Pain intensity and effectiveness of analgesics | Brief Pain Inventory-Short Form - Pain Severity Index | Post-operatively at 2 years |
| Satisfaction with knee surgery | Forgotten Joint Score | Post-operatively at 6 weeks, 6 months, 1 year and 2 years |
| Satisfaction with knee surgery | Forgotten Joint Score | Post-operatively at 6 weeks |
| Satisfaction with knee surgery | Forgotten Joint Score | Post-operatively at 6 months |
| Satisfaction with knee surgery | Forgotten Joint Score | Post-operatively at 1 year |
| Satisfaction with knee surgery | Forgotten Joint Score | Post-operatively at 2 years |
| Function | Oxford knee score | post-operatively at 6 weeks |
| Function | Oxford knee score | post-operatively at 6 months |
| Function | Oxford knee score | pre-operatively |
| Function | Oxford knee score | post-operatively at 2 years |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |