Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment
- Conditions
- Arthropathy of Knee
- Interventions
- Other: Mechanical alignmentOther: Functional alignment
- Registration Number
- NCT06259032
- Lead Sponsor
- Rajavithi Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Age 20-80 years
- Symptomatic bilateral knee Osteoarthritis requiring primary TKA
- Willing to undergo bilateral simultaneous TKA
- Able to give informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mechanical alignment Mechanical alignment - Functional alignment Functional alignment -
- Primary Outcome Measures
Name Time Method Radiographic outcomes : Hip-knee-ankle angle 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 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 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 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 Outcome Measures
Name Time Method Quality of Life score : EQ-5D-5L pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks assess patient five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, Index scores range from -0.42 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS) pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks a questionnaire assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Forgotten Joint Score pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks consists of 12 questions and is transform on a 0-100 scale.The higher the score, the less the patient is aware of their affected joint when performing daily activities
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 evaluation of the clinical status of the ankle-hindfoot, both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Trial Locations
- Locations (1)
Rajavithi Hospital
🇹🇭Ratchathewi, Bangkok, Thailand