Clinical trial NCT06323577: Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
TKA
Keywords: restrict kinematic alignment
mechanical alignment
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Forgotten joint score
timeFrame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Secondary outcomes:
measure: Modified WOMAC score
timeFrame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
measure: Range of motion
timeFrame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
measure: Pain score
timeFrame: 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
measure: Hip knee ankle angle
timeFrame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
measure: Complications
timeFrame: Until 2 years after surgery
measure: Incidence of soft tissue releasing
timeFrame: During surgery
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University
state: Pathum Thani
Study officials:
References:
citation: 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.
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.
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.