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The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Arm | Active Comparator | Subjects enrolled into this arm of the study will receive an ATTUNE primary total knee replacement that has been implanted using manual instrumentation which is the current standard of care at the participating sites. |
|
| Robotic-Assisted Arm | Experimental | Subjects enrolled into this arm will receive an ATTUNE primary total knee replacement that has been implanted with the use of the VELYS Robotic-Assisted Solution device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement | Device | Subjects will be implanted with an ATTUNE Primary total knee replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks. | The primary objective of this clinical investigation is to evaluate whether the accuracy to plan of the long leg alignment achieved with VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks. | The accuracy of the distal femoral varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient with 1 (meaning full health) and 0 (meaning a state as bad as being dead). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian J Leslie, PhD | DePuy Synthes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States | ||
| Cuyuna Regional Medical Center |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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Of the 34 subjects withdrawn without receiving the planned treatment, 8 were withdrawn due to a significant delay in having their procedure performed, 7 were withdrawn due to not meeting the inclusion/exclusion criteria, 6 were withdrawn due to the surgeon using an out of scope implant, 4 withdrew due to their insurance not covering surgery, 5 withdrew their consent, 3 were withdrawn due to the specified instrumentation not being available and one was withdrawn due to a change in the surgeon.
A total of 200 subjects were recruited into the study and received the intended treatment. An additional 34 subjects were recruited during the study but did not receive the planned treatment and were withdrawn and replaced in the study as allowed in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | Robotic-Assisted |
| FG001 | Control Arm | Manual Instrumentation |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2022 |
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Quantitative analysis of the X-rays will be conducted by a third party who will be blinded to the treatment group.
| Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks | The accuracy of the proximal tibial varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | 12 weeks |
| Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks | The accuracy of the femoral component flexion angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | 12 weeks |
| Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks | The accuracy of the Tibial slope angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | 12 weeks |
| Type and Frequency of Adverse Events | Rate of local Adverse events and local serious adverse events reported within the first 90 days and the first year post surgery. Local means at the site of the procedure (i.e. the operated Knee). Serious adverse events are events that required medical or surgical intervention to prevent a serious impairment to health. | 12 weeks, 1 year |
| Soft Tissue Damage | Investigators conducted an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts. | Day of operation (intraoperative) |
| 1 year |
| Forgotten Joint Score (FJS-12) | The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is. | 12 weeks and 1 year |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 12 weeks, 1 year |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 12 weeks, 1 year |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 12 weeks, 1 year |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 12 weeks, 1 year |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 12 weeks, 1 year |
| Subject Satisfaction With Knee Replacement | A single patient reported question that asks the patient to score their level of satisfaction with their knee from 0-10, with 0 being fully satisfied and 10 being fully unsatisfied | 12 weeks, 1 year |
| Pain - Change From Baseline | Subjects are asked how much knee pain they have had in the last week while resting (0-10) and during activity (0-10) with 0 being no pain and 10 being worst pain, therefore lower score is a better outcome. | 12 weeks, 1 year |
| Learning Curve | The effect of learning curve on the accuracy was assessed by comparing the accuracy between the first 10 cases each surgeon completed and the subsequent cases. The accuracy was assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome. | 12 Weeks |
| Crosby |
| Minnesota |
| 56441 |
| United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Campbell Clinic | Germantown | Tennessee | 38138 | United States |
| Proliance Orthopedic Associates | Renton | Washington | 98055 | United States |
|
| Intent to Treat and Completed 12 Week Follow up Per Protocol | Including required X-rays |
|
| COMPLETED | Completed 1 year follow up (safety analysis set) |
|
| NOT COMPLETED |
|
|
| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Robotic-Assisted |
| BG001 | Control Arm | Manual Instrumentation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Knees |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| 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 | Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks. | The primary objective of this clinical investigation is to evaluate whether the accuracy to plan of the long leg alignment achieved with VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome. | Intent to Treat | Posted | Least Squares Mean | Standard Deviation | Degrees | 12 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks. | The accuracy of the distal femoral varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | Per Protocol | Posted | Least Squares Mean | Standard Deviation | Degrees | 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks | The accuracy of the proximal tibial varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | Per Protocol | Posted | Least Squares Mean | Standard Deviation | Degrees | 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks | The accuracy of the femoral component flexion angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | Per Protocol | Posted | Least Squares Mean | Standard Deviation | Degrees | 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks | The accuracy of the Tibial slope angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome. | Per Protocol | Posted | Least Squares Mean | Standard Deviation | Degrees | 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Type and Frequency of Adverse Events | Rate of local Adverse events and local serious adverse events reported within the first 90 days and the first year post surgery. Local means at the site of the procedure (i.e. the operated Knee). Serious adverse events are events that required medical or surgical intervention to prevent a serious impairment to health. | Safety Analysis Set | Posted | Number | Number of subjects | 12 weeks, 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Soft Tissue Damage | Investigators conducted an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts. | Safety Set | Posted | Number | participants | Day of operation (intraoperative) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient with 1 (meaning full health) and 0 (meaning a state as bad as being dead). | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Forgotten Joint Score (FJS-12) | The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is. | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks and 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject Satisfaction With Knee Replacement | A single patient reported question that asks the patient to score their level of satisfaction with their knee from 0-10, with 0 being fully satisfied and 10 being fully unsatisfied | Per Protocol Analysis Set The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data during the PROM collection. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pain - Change From Baseline | Subjects are asked how much knee pain they have had in the last week while resting (0-10) and during activity (0-10) with 0 being no pain and 10 being worst pain, therefore lower score is a better outcome. | Per Protocol Analysis Set. The number analyzed at each time point and for each metrics varies due to patients either being lost to follow up between visits or there being missing data. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks, 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Learning Curve | The effect of learning curve on the accuracy was assessed by comparing the accuracy between the first 10 cases each surgeon completed and the subsequent cases. The accuracy was assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome. | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | Degrees | 12 Weeks |
|
|
From baseline (Day 0 - including the procedure) up to the end of the study (1 year)
The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Arm | Robotic-Assisted | 1 | 100 | 16 | 100 | 32 | 100 |
| EG001 | Control Arm | Manual Instrumentation | 0 | 100 | 28 | 100 | 35 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Post Procedural Infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Device Related Infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Bursitis Infective | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Arthropathy disruption | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Tendon Disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Events |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment | Systematic - of contralateral side |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment | Local/Operative Site Event |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Febrileneutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Systemic Mycosis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment | On contralateral side |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vulval Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pulmonaryembolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Ligament Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthritis Infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Use Error | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint Noise | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Device Loosening | Product Issues | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Skin Necrosis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Ligament Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
|
Adverse events were coded as reported by sites per MeDRA. This resulted in some spreading of AEs. For example, "swelling" and "knee swelling" were coded differently according to best practice. Future publications will consolidate similar coded events and clarify which were combined.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Leslie | DePuy Synthes | N/A | ileslie1@its.jnj.com |
| Oct 11, 2024 |
| Prot_SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
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