Clinical trial NCT06259032: Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment
Official title: Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy of Knee
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2024-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.

Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.


Eligibility criteria: Inclusion Criteria:

* Age 20-80 years
* Symptomatic bilateral knee Osteoarthritis requiring primary TKA
* Willing to undergo bilateral simultaneous TKA
* Able to give informed consent

Exclusion Criteria:

* ligament deficiency requiring constrained prosthesis
* bone loss with augmentation need
* history of fracture around knee or previous osteotomy
* history of ankle fracture
* patient with neuromuscular disorder or movement disorder
* patient is unable to attend the study follow-up program

Primary outcomes:
measure: Radiographic outcomes : Hip-knee-ankle angle
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
measure: Radiographic outcomes : Tibial plafond inclination
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
measure: Radiographic outcomes :Talar inclination
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
measure: Radiographic outcomes : Tibiotalar tilt angle
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Secondary outcomes:
measure: Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
measure: Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
measure: Quality of Life score : EQ-5D-5L
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
measure: Forgotten Joint Score
timeFrame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Other outcomes:
measure: Other outcomes : soft tissue release
timeFrame: intraoperative
measure: Other outcomes : operative time
timeFrame: intraoperative
measure: Other outcomes : blood loss
timeFrame: post operative with in 2 days
measure: Other outcomes : pain score (Visual analog scale)
timeFrame: post-operative at 2,4,8,12 weeks
measure: Other outcomes : Range of knee motion
timeFrame: post-operative at 2,4,8,12 weeks
measure: complications
timeFrame: post-operative at 2,4,8,12 weeks
Locations:
city: Ratchathewi
country: Thailand
facility: Rajavithi Hospital
state: Bangkok
Study officials:
References: