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| Name | Class |
|---|---|
| St John of God Private Hospital Subiaco | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functionally aligned Total Knee Arthroplasty | Active Comparator | Knee arthroplasty performed using a functional alignment theory |
|
| Mechanical axis aligned Total Knee Arthroplasty | Active Comparator | Knee arthroplasty performed using a mechanical alignment theory |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functionally Aligned Total Knee Arthroplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Preoperatively and 2 years postoperatively |
| 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. | Preoperatively and 2 years postoperatively |
| 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. | Preoperatively and 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gavin Clark | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth Hip and Knee | Subiaco | Western Australia | 6008 | Australia | ||
| St John of God Private Hopsital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34372888 | Derived | Steer R, Tippett B, Khan RN, Collopy D, Clark G. A prospective randomised control trial comparing functional with mechanical axis alignment in total knee arthroplasty: study protocol for an investigator initiated trial. Trials. 2021 Aug 9;22(1):523. doi: 10.1186/s13063-021-05433-z. |
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Not shared - for confidentiality of participants
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
100 cases were randomised. 1 MA case was then removed from cohort analysis due to protocol changes in alignment technique during surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Preoperatively and 2 years postoperatively |
|
Adverse events were monitored for each participant from the time of enrolment (baseline) through to their final study visit (2 years post-operative).
Both methods of knee alignment are already being performed as standard of care for both surgeons. There are no additional risks to the patient stemming from either trial intervention, apart from routine risk of surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MUA | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Serene Lee, Orthopaedic Research Officer | Perth Hip & Knee | 64891720 | research@hipnknee.com.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 14, 2021 | Jun 16, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Mechanically Aligned Total Knee Arthroplasty | Procedure | 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 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 | 6 weeks, 3 months, 1 year, 2 years |
| 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" | Preop, and post-operatively at 3 months, 1 year and 2 years |
| 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. | Preop, 3 months, 1 Year and 2 years |
| 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) | Intraoperatively |
| 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. | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. |
| 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. | 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) | Difference in operated knee pain as measured by Visual Analogue Scale for pain (VAS). Scale 0-100 with higher scores meaning worse outcome. | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. |
| 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. | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. |
| Subiaco |
| Western Australia |
| 6008 |
| Australia |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively and 2 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | deg | Preoperatively and 2 years postoperatively |
|
|
|
| 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. | Not Posted | 3 Months post-operatively | Participants |
| 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 | Not Posted | 6 weeks, 3 months, 1 year, 2 years | Participants |
| 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" | Not Posted | Preop, and post-operatively at 3 months, 1 year and 2 years | Participants |
| 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. | Not Posted | Preop, 3 months, 1 Year and 2 years | Participants |
| 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) | Not Posted | Intraoperatively | Participants |
| 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. | Not Posted | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. | Participants |
| 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. | Not Posted | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. | Participants |
| 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. | Not Posted | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. | Participants |
| 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. | Not Posted | Measured Pre-operatively and at 3 month, 1 year and 2 years post operatively. | Participants |
| 0 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 49 | 1 | 49 | 0 | 49 |
| Paroxsymal SVT post operative | Cardiac disorders | Systematic Assessment |
|
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