Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty (FATKAvsMATKA)
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|ClinicalTrials.gov Identifier: NCT04748510|
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Osteo Arthritis Knee||Procedure: Functionally Aligned Total Knee Arthroplasty Procedure: Mechanically Aligned Total Knee Arthroplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||February 2024|
Active Comparator: Functionally aligned Total Knee Arthroplasty
Knee arthroplasty performed using a functional alignment theory
Procedure: Functionally Aligned Total Knee Arthroplasty
Femoral + tibial osteotomy planned for equal resection of femoral condyles to replicate patient anatomy. In coronal plane, distal femoral resection of 6.5mm subchondral bone from medial + lateral condyles, adjusted 1-3mm for compensation of wear. Proximal tibia, 7mm resection from subchondral bone from medial + lateral tibial plateau. Sagittal plane, resection angle determined intraoperatively to closely match native femoral flexion + tibial slope. Axial plane: posterior femoral resection 6.5mm from the subchondral bone of medial and lateral posterior condyles. Tibial rotation aligned to Akagi's line. Adjustments will be made to bony alignment to balance soft tissues within boundaries of 6° varus/3° valgus HKA alignment. Femoral component alignment limited to 6° valgus/3° varus in coronal plane. Tibial alignment limited 6° varus/3° valgus in coronal plane. Combined flexion of components limited to 10° flexion. Soft tissue release if balance within boundaries not achieved.
Active Comparator: Mechanical axis aligned Total Knee Arthroplasty
Knee arthroplasty performed using a mechanical alignment theory
Procedure: Mechanically Aligned Total Knee Arthroplasty
Tibial and femoral osteotomies in the coronal plane will be planned perpendicular to the tibial and femoral mechanical axes respectively to achieve neutral overall alignment. Soft tissue balance will be assessed and minor adjustments to bony alignment made to balance the knees with a maximal adjustment of two degrees valgus and two degrees varus of coronal alignment from neutral. Femoral rotation will be planned to surgical epicondylar axis and adjustments to rotation made to allow equal flexion and extension balance (to within 1mm). If balance can not be achieved within these boundaries then soft tissue release will be undertaken. In the sagittal plane, 0-3° degrees of posterior tibial slope and 0-5° of femoral component flexion will be used to optimise implant sizing whilst preventing notching. In the axial plane, the tibial component aligned to Akagi's line, which connects the medial border of the patellar tendon attachment to the middle of the posterior cruciate ligament.
- Difference in Forgotten Joint Score after 2 years [ Time Frame: Preoperatively and 2 years postoperatively ]Difference in relative change in Forgotten joint score between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-100 with higher scores being a better outcome
- Difference in Oxford Knee Score after 2 years [ Time Frame: Preoperatively and 2 years postoperatively ]Difference in relative change in Oxford Knee Score (OKS) between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-48 with higher scores being a better outcome.
- Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively. [ Time Frame: Preoperatively and 2 years postoperatively ]Difference in range of motion via goniometry preoperatively and postoperatively at 2 years
- Determine lower limb alignment achieved with both alignment techniques [ Time Frame: 3 Months post-operatively ]Lower limb alignment as assessed using standing long leg x-rays performed postoperatively at 3 months. Measurements of the hip-knee-angle (HKA), medial proximal tibial angle (MPTA) and lateral distal femoral angle (LDFA). Also evidence of imbalance with implant lift off will be measured.
- Difference in analgesia requirements between patients in alignment groups [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]
Determine if there are any differences in analgesic requirements based on alignment method used.
Inpatient medical records will be utilised to obtain analgesia requirements as inpatient Questionnaires will be used to obtain analgesia usage at remaining timepoints. Analgesia usage will be converted to morphine equivalent dosages for comparison
- Difference in sagittal stability of the knee post replacement [ Time Frame: Preop, and post-operatively at 3 months, 1 year and 2 years ]Determine whether alignment method utilized has an effect on the sagittal stability of the knee post replacement, as measure with an arthrometer "Lachmeter"
- Difference in functional outcomes (measured as maximal voluntary contraction) of knee flexion and extension between alignment groups [ Time Frame: Preop, 3 months, 1 Year and 2 years ]
Determine whether alignment method utilized has an effect on functional outcomes.
Measured as Maximal voluntary isometric knee flexion and extension forces as measured via hand-held dynamometry.
- Intra-operative balance achieved with different alignment techniques. [ Time Frame: Intraoperatively ]Surgeon blinded measurement of intraoperative balance achieved with Verasense sensor (smaller cohort) Secondary outcome  To determine if there is a difference in knee kinematics between the two techniques. Measurement of knee kinematics with Verasense sensor to assess presence or absence of medial pivot (smaller cohort)
- Difference in clinical outcomes as measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR) [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]Difference in operated knee outcome on Koos JR scale. Scale 0-100 where higher scores mean better outcome.
- Difference in clinical outcomes as measured in European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D-5L). [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]Difference in overall by Visual Analogue Scale for overall health (VAS). Scale: Five dimensions combined into a 5-digit number lower numbers represent better outcomes. Addition of overall health VAS Scale 0-100 with higher score being better outcome.
- Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS) [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome.
- Difference in clinical outcomes as measured by Kujala score- a measure of anterior knee pain and best clinical score for patellofemoral function [ Time Frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. ]Difference in clinical outcomes as measured by Kujala score. Scale 0-100 with higher scores meaning better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748510
|Contact: Gavin Clarkemail@example.com|
|Contact: Beth L Tippettfirstname.lastname@example.org|
|Australia, Western Australia|
|Perth Hip and Knee||Recruiting|
|Subiaco, Western Australia, Australia, 6008|
|Contact: Gavin Clark +61864891777 email@example.com|
|Contact: Beth Tippett +61 8 6489 1777 firstname.lastname@example.org|
|Sub-Investigator: Dermot Collopy|
|Principal Investigator: Gavin Clark|
|St John of God Private Hopsital||Active, not recruiting|
|Subiaco, W, Australia, 6008|
|Principal Investigator:||Gavin Clark||Principal Investigator|