Osteoarthritis, Osteo Arthritis Knee
Conditions
Keywords
OA, Arthritis, Knee, Osteoarthritis
Brief summary
The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). These outcomes will be used to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA).
Detailed description
This project is being conducted by Perth Hip and Knee Clinic. The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient's leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA).
Interventions
PROCEDUREFunctionally 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.
PROCEDUREMechanically 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.
Sponsors
St John of God Private Hospital Subiaco
Perth Hip and Knee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient has symptomatic knee osteoarthritis requiring primary TKA * Patient and surgeon are in agreement that TKA is the most appropriate treatment * Patient is fit for surgical intervention following review by surgeon * Patient is between 45-75 years of age at time of surgery, computer literate, and able to complete patient-reported outcome measures independently. * Patient must be capable of giving informed consent and agree to comply with the postoperative review program. * Patient must be a permanent resident in an area accessible to the study site * Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken * Patient has tried non-pharmacologic therapies including: patient education, self-management programs, aerobic exercise, weight loss, physiotherapy and occupational therapy * Patient has tried appropriate pharmacologic therapies including: regular paracetamol and NSAIDS if appropriate
Exclusion criteria
* Patient is not suitable for routine primary TKA. E.g., patient has ligament deficiency that requires a constrained prosthesis * Interoperative requirement for a more constrained implant. * Intraoperative requirement for the Posterior Cruciate Ligament to be released. These patients will be still included in the study, but analyzed with an intention-to-treat principle. * Patient has bone loss that requires augmentation * Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA (e.g., post-high tibial or distal femoral osteotomy) * Patient requires a polyethylene inset of 13mm or greater. * Patient is immobile or has another neurological condition affecting musculoskeletal function * Patient is less than 44 years of age or greater than 76 years of age * Patient is a compensable patient. I.e., Worker's compensation claim or motor vehicle accident. * Patient is already enrolled in another concurrent clinical trial * Patient is unable or unwilling to sign the informed consent form specific to this study * Patient is unable to attend the follow-up program * Patient is non-resident in local area or expected to leave the catchment area postoperatively * Patients who lacks capacity to provide consent, or the ability to understand the study protocol due to a cognitive condition (e.g., Dementia) * Patient is unable to communicate effectively in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forgotten Joint Score After 2 Years From Baseline | Preoperatively and 2 years postoperatively | Difference in relative change in Forgotten Joint Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-100 with higher scores being a better outcome |
| Change in Oxford Knee Score After 2 Years From Baseline | Preoperatively and 2 years postoperatively | Difference in relative change in Oxford Knee Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-48 with higher scores being a better outcome. |
| Change in Range of Motion After 2 Years From Baseline | Preoperatively and 2 years postoperatively | Difference in relative change in range of motion via goniometry (2 years post-operatively compared to preoperatively) between FA and MA patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Functional Outcomes (Measured as Maximal Voluntary Contraction) of Knee Flexion and Extension Between Alignment Groups | 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. | Intraoperatively | Surgeon blinded measurement of intraoperative balance achieved with Verasense sensor (smaller cohort) Secondary outcome \[6\] 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) | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. | Difference in operated knee outcome on Koos JR scale between FA and MA patients. Scale 0-100 where higher scores mean better outcome. |
| Determine Lower Limb Alignment Achieved With Both Alignment Techniques | 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 Operated Knee Pain as Measured by Visual Analogue Scale for Pain (VAS) | 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 | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. | Difference in clinical outcomes as measured by Kujala score between FA and MA patients. Scale 0-100, with higher scores indicating better outcome. |
| Difference in Clinical Outcomes as Measured in European Quality of Life Questionnaire With 5 Dimensions for Adults (EQ-5D-5L). | 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 Analgesia Requirements Between Patients in Alignment Groups | 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 | 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 |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Functionally Aligned Total Knee Arthroplasty Knee arthroplasty performed using a functional alignment theory
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. | 50 |
| Mechanical Axis Aligned Total Knee Arthroplasty Knee arthroplasty performed using a mechanical alignment theory
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. | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | Functionally Aligned Total Knee Arthroplasty | Mechanical Axis Aligned Total Knee Arthroplasty | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 6.2 | 65.4 years STANDARD_DEVIATION 7.3 | 65.2 years STANDARD_DEVIATION 6.8 |
| BMI | 31.3 kg/m^2 STANDARD_DEVIATION 6.4 | 31.0 kg/m^2 STANDARD_DEVIATION 5.2 | 31.2 kg/m^2 STANDARD_DEVIATION 5.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 24 Participants | 52 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 1 / 50 | 1 / 49 |
Outcome results
Primary
Change in Forgotten Joint Score After 2 Years From Baseline
Difference in relative change in Forgotten Joint Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-100 with higher scores being a better outcome
Time frame: Preoperatively and 2 years postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | Change in Forgotten Joint Score After 2 Years From Baseline | 50.1 score on a scale | Standard Deviation 28.3 |
| Mechanical Axis Aligned Total Knee Arthroplasty | Change in Forgotten Joint Score After 2 Years From Baseline | 46.4 score on a scale | Standard Deviation 32.4 |
Primary
Change in Oxford Knee Score After 2 Years From Baseline
Difference in relative change in Oxford Knee Score (2 years post-operatively compared to preoperatively) between FA and MA patients. Scale 0-48 with higher scores being a better outcome.
Time frame: Preoperatively and 2 years postoperatively
Population: 11 patients did not provide responses for this outcome measure, resulting in missing scores. Some of these participants did complete other study questionnaires but were lost to follow-up for this specific assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | Change in Oxford Knee Score After 2 Years From Baseline | 17.0 score on a scale | Standard Deviation 7.5 |
| Mechanical Axis Aligned Total Knee Arthroplasty | Change in Oxford Knee Score After 2 Years From Baseline | 17.2 score on a scale | Standard Deviation 8.6 |
Primary
Change in Range of Motion After 2 Years From Baseline
Difference in relative change in range of motion via goniometry (2 years post-operatively compared to preoperatively) between FA and MA patients.
Time frame: Preoperatively and 2 years postoperatively
Population: 18 participants were lost to in-person clinical follow-up, resulting in missing range-of-motion scores. Reasons for loss to follow-up included cancer diagnosis, relocation outside the Perth metropolitan area, appointment cancellations or refusals, and inability to contact the participants. However, some of these individuals completed the study questionnaires and were lost to follow-up only for the range-of-motion assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | Change in Range of Motion After 2 Years From Baseline | 2.8 deg | Standard Deviation 9.9 |
| Mechanical Axis Aligned Total Knee Arthroplasty | Change in Range of Motion After 2 Years From Baseline | 2.8 deg | Standard Deviation 9.3 |
Secondary
Determine Lower Limb Alignment Achieved With Both Alignment Techniques
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.
Time frame: 3 Months post-operatively
Secondary
Difference in Analgesia Requirements Between Patients in Alignment Groups
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
Time frame: 6 weeks, 3 months, 1 year, 2 years
Secondary
Difference in Clinical Outcomes as Measured by Kujala Score- a Measure of Anterior Knee Pain and Best Clinical Score for Patellofemoral Function
Difference in clinical outcomes as measured by Kujala score between FA and MA patients. Scale 0-100, with higher scores indicating better outcome.
Time frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary
Difference in Clinical Outcomes as Measured in European Quality of Life Questionnaire With 5 Dimensions for Adults (EQ-5D-5L).
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.
Time frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary
Difference in Clinical Outcomes as Measured in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Score (KoosJR)
Difference in operated knee outcome on Koos JR scale between FA and MA patients. Scale 0-100 where higher scores mean better outcome.
Time frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary
Difference in Functional Outcomes (Measured as Maximal Voluntary Contraction) of Knee Flexion and Extension Between Alignment Groups
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.
Time frame: Preop, 3 months, 1 Year and 2 years
Secondary
Difference in Operated Knee Pain as Measured by Visual Analogue Scale for Pain (VAS)
Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome.
Time frame: Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively.
Secondary
Difference in Sagittal Stability of the Knee Post Replacement
Determine whether alignment method utilized has an effect on the sagittal stability of the knee post replacement, as measure with an arthrometer Lachmeter
Time frame: Preop, and post-operatively at 3 months, 1 year and 2 years
Secondary
Intra-operative Balance Achieved With Different Alignment Techniques.
Surgeon blinded measurement of intraoperative balance achieved with Verasense sensor (smaller cohort) Secondary outcome \[6\] 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)
Time frame: Intraoperatively