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The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.
The main question[s] it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restricted kinematic alignment | Experimental |
| |
| Mechanical alignment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restricted kinematic alignment | Procedure | TKA using restricted kinematic alignment under robotic assisted surgery (MAKO). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forgotten joint score | Point 0-100 (0 mean worst, 100 mean best) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Modified WOMAC score | Point 0-96 (0 mean best, 100 mean worst) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery |
| Range of motion | Using long arm goniometer (degrees) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University | Recruiting | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35093548 | Background | Elbuluk AM, Jerabek SA, Suhardi VJ, Sculco PK, Ast MP, Vigdorchik JM. Head-to-Head Comparison of Kinematic Alignment Versus Mechanical Alignment for Total Knee Arthroplasty. J Arthroplasty. 2022 Aug;37(8S):S849-S851. doi: 10.1016/j.arth.2022.01.052. Epub 2022 Jan 31. | |
| 31591010 | Background | McEwen PJ, Dlaska CE, Jovanovic IA, Doma K, Brandon BJ. Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery. J Arthroplasty. 2020 Feb;35(2):443-450. doi: 10.1016/j.arth.2019.08.064. Epub 2019 Sep 5. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Mechanical alignment | Procedure | TKA using mechanical alignment under robotic assisted surgery (MAKO). |
|
| 6 weeks, 3months, 6 months, 1 year and 2 years after surgery |
| Pain score | Using visual analog scale (0-10, 0 mean best, 10 mean worst) | every 6 hours for 2 days after surgery then once a day for 2 weeks after surgery then once a week until 3 months after surgery |
| Hip knee ankle angle | Evaluate by long radiograph (degrees) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery |
| Complications | For example periprosthetic fracture, infection or aspetic loosening | Until 2 years after surgery |
| Incidence of soft tissue releasing | Record soft tissue releasing intraoperative | During surgery |
| 36403396 | Background | Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17. |
| D012216 |
| Rheumatic Diseases |