Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323577
• Other study ID #: TUH rKA vs MA TKA
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

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