Osteoarthritis, Knee Clinical Trial
Official title:
Comparison of Functional Outcomes in Restricted Kinematic Alignment and Mechanical Alignment in Robotic Assisted Simultaneous Bilateral Total Knee Arthroplasty. A Randomized Controlled Trial
Verified date | March 2024 |
Source | Thammasat University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: - Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients? - Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 40-80 years - Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty - ASA classification I-II Exclusion Criteria: - Valgus deformity - BMI > 40kg/m2 - History of previous knee surgery - Active infection of the knee joint |
Country | Name | City | State |
---|---|---|---|
Thailand | Thammasat University | Khlong Luang | Pathum Thani |
Lead Sponsor | Collaborator |
---|---|
Thammasat University Hospital |
Thailand,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forgotten joint score | Point 0-100 (0 mean worst, 100 mean best) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery | |
Secondary | Modified WOMAC score | Point 0-96 (0 mean best, 100 mean worst) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery | |
Secondary | Range of motion | Using long arm goniometer (degrees) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery | |
Secondary | 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 | |
Secondary | Hip knee ankle angle | Evaluate by long radiograph (degrees) | 6 weeks, 3months, 6 months, 1 year and 2 years after surgery | |
Secondary | Complications | For example periprosthetic fracture, infection or aspetic loosening | Until 2 years after surgery | |
Secondary | Incidence of soft tissue releasing | Record soft tissue releasing intraoperative | During surgery |
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