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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06323577
Other study ID # TUH rKA vs MA TKA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 14, 2024
Est. completion date May 31, 2026

Study information

Verified date March 2024
Source Thammasat University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Restricted kinematic alignment
TKA using restricted kinematic alignment under robotic assisted surgery (MAKO).
Mechanical alignment
TKA using mechanical alignment under robotic assisted surgery (MAKO).

Locations

Country Name City State
Thailand Thammasat University Khlong Luang Pathum Thani

Sponsors (1)

Lead Sponsor Collaborator
Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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

Outcome

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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