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Clinical Trials/NCT06259032
NCT06259032
Completed
Not Applicable

Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial

Rajavithi Hospital1 site in 1 country20 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthropathy of Knee
Sponsor
Rajavithi Hospital
Enrollment
20
Locations
1
Primary Endpoint
Radiographic outcomes : Hip-knee-ankle angle
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Radiographic outcomes : Hip-knee-ankle angle

Time Frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond

Radiographic outcomes :Talar inclination

Time Frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

angle in degree between talar dome and vertical axis

Radiographic outcomes : Tibial plafond inclination

Time Frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

angle in degree between subchondral plate of distal tibial articular surface and vertical axis

Radiographic outcomes : Tibiotalar tilt angle

Time Frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

angle in degree between subchondral plate of distal tibial articular surface and talar dome

Secondary Outcomes

  • Quality of Life score : EQ-5D-5L(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)
  • Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)
  • Forgotten Joint Score(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)
  • Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)

Study Sites (1)

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