Osteoarthritis, Osteo Arthritis Knee
Conditions
Keywords
Arthroplasty, Knee, Robotic-Assisted, VELYS, Accuracy
Brief summary
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.
Interventions
DEVICETotal Knee Replacement
Subjects will be implanted with an ATTUNE Primary total knee replacement.
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Quantitative analysis of the X-rays will be conducted by a third party who will be blinded to the treatment group.
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive. 2. Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable candidate for primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae. 3. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor 4. Subject is currently not permanently bedridden, as determined by the Investigator 5. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. 6. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English. 7. Subject's pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery.
Exclusion criteria
1. The Subject is a woman who is pregnant or lactating. 2. Contralateral knee has already been enrolled in this study. 3. Subject had a contralateral amputation. 4. Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. 5. Subject has an active local or systemic infection 6. Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy) 7. Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. 8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. 9. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks | 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. |
| Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks | 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. |
| Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks. | 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. |
| Type and Frequency of Adverse Events | 12 weeks, 1 year | 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. |
| Soft Tissue Damage | Day of operation (intraoperative) | Investigators conducted an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts. |
| Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction With Knee Replacement | 12 weeks, 1 year | 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 |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | 1 year | 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). |
| Learning Curve | 12 Weeks | 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. |
| Pain - Change From Baseline | 12 weeks, 1 year | 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. |
| Forgotten Joint Score (FJS-12) | 12 weeks and 1 year | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | 12 weeks, 1 year | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | 12 weeks, 1 year | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | 12 weeks, 1 year | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | 12 weeks, 1 year | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | 12 weeks, 1 year | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Study Arm Robotic-Assisted | 100 |
| Study Arm Robotic-Assisted | 100 |
| Control Arm Manual Instrumentation | 100 |
| Control Arm Manual Instrumentation | 100 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Protocol Violation | 7 | 13 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control Arm | Total | Study Arm |
|---|---|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 9.05 | 65.5 Years STANDARD_DEVIATION 8.72 | 66.6 Years STANDARD_DEVIATION 8.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 189 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 41 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 68 Participants | 149 Participants | 81 Participants |
| Sex: Female, Male Female | 53 Participants | 101 Participants | 48 Participants |
| Sex: Female, Male Male | 47 Participants | 99 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 100 | 0 / 100 |
| other Total, other adverse events | 32 / 100 | 35 / 100 |
| serious Total, serious adverse events | 16 / 100 | 28 / 100 |
Outcome results
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.
Time frame: 12 weeks
Population: Intent to Treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks. | 2.2 Degrees | Standard Deviation 1.77 |
| Control Arm | Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks. | 2.5 Degrees | Standard Deviation 1.76 |
p-value: <0.0001t-test, 1 sided
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.
Time frame: 12 weeks
Population: Per Protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks | 1.9 Degrees | Standard Deviation 1.42 |
| Control Arm | Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks | 2.8 Degrees | Standard Deviation 1.89 |
p-value: 0.0004t-test, 2 sided
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.
Time frame: 12 weeks
Population: Per Protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks. | 1.4 Degrees | Standard Deviation 1.16 |
| Control Arm | Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks. | 2.0 Degrees | Standard Deviation 1.49 |
p-value: 0.0058t-test, 2 sided
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.
Time frame: 12 weeks
Population: Per Protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks | 1.2 Degrees | Standard Deviation 0.95 |
| Control Arm | Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks | 1.6 Degrees | Standard Deviation 1.15 |
p-value: 0.0282t-test, 2 sided
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.
Time frame: 12 weeks
Population: Per Protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks | 1.6 Degrees | Standard Deviation 1.25 |
| Control Arm | Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks | 2.7 Degrees | Standard Deviation 2.05 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: Day of operation (intraoperative)
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Arm | Soft Tissue Damage | Incidence of medial collateral ligament being compromised intraoperatively. | 0 participants |
| Study Arm | Soft Tissue Damage | Incidence of patella tendon being compromised intraoperatively. | 0 participants |
| Study Arm | Soft Tissue Damage | Incidence of lateral collateral ligament being compromised intraoperatively. | 0 participants |
| Study Arm | Soft Tissue Damage | Incidence of posterior cruciate ligament being compromised intraoperatively | 0 participants |
| Study Arm | Soft Tissue Damage | Incidence of posterior lateral capsule being compromised intraoperatively. | 0 participants |
| Study Arm | Soft Tissue Damage | Incidence of posterior medial capsule being compromised intraoperatively. | 0 participants |
| Control Arm | Soft Tissue Damage | Incidence of posterior lateral capsule being compromised intraoperatively. | 0 participants |
| Control Arm | Soft Tissue Damage | Incidence of posterior medial capsule being compromised intraoperatively. | 0 participants |
| Control Arm | Soft Tissue Damage | Incidence of posterior cruciate ligament being compromised intraoperatively | 1 participants |
| Control Arm | Soft Tissue Damage | Incidence of medial collateral ligament being compromised intraoperatively. | 2 participants |
| Control Arm | Soft Tissue Damage | Incidence of patella tendon being compromised intraoperatively. | 0 participants |
| Control Arm | Soft Tissue Damage | Incidence of lateral collateral ligament being compromised intraoperatively. | 0 participants |
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.
Time frame: 12 weeks, 1 year
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Local Adverse Events with 1 year of the procedure. | 25 Number of subjects |
| Study Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Serious Local Adverse Events within 1 year of the procedure | 6 Number of subjects |
| Study Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Local Adverse Events within 90 days of the procedure | 21 Number of subjects |
| Study Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Serious Local Adverse Events within 90 days of the procedure | 5 Number of subjects |
| Control Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Serious Local Adverse Events within 90 days of the procedure | 12 Number of subjects |
| Control Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Local Adverse Events with 1 year of the procedure. | 29 Number of subjects |
| Control Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Local Adverse Events within 90 days of the procedure | 27 Number of subjects |
| Control Arm | Type and Frequency of Adverse Events | Number of subjects who experienced a Serious Local Adverse Events within 1 year of the procedure | 16 Number of subjects |
Comparison: Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 1 year of the procedure.p-value: 0.633Chi-squared
Comparison: Comparison between the proportion of Robotic and Manual subjects who had a serious local adverse event within 1 year of the procedure.p-value: 0.04Fisher Exact
Comparison: Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 90 days of the procedure.p-value: 0.4079Chi-squared
Comparison: Comparison between the proportion of Robotic and Manual subjects who had a local serious adverse event within 90 days of the procedure.p-value: 0.1262Chi-squared
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).
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | Change from Baseline Pre op to 1 year | 0.19 scores on a scale | Standard Deviation 0.159 |
| Study Arm | EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | Change from Baseline Pre op to 12 weeks | 0.15 scores on a scale | Standard Deviation 0.17 |
| Control Arm | EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | Change from Baseline Pre op to 1 year | 0.20 scores on a scale | Standard Deviation 0.195 |
| Control Arm | EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline | Change from Baseline Pre op to 12 weeks | 0.16 scores on a scale | Standard Deviation 0.186 |
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 yearp-value: 0.6662t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeksp-value: 0.8154t-test, 2 sided
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.
Time frame: 12 weeks and 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Forgotten Joint Score (FJS-12) | FJS at 12 Weeks | 35.4 scores on a scale | Standard Deviation 25.73 |
| Study Arm | Forgotten Joint Score (FJS-12) | FJS at 1 year | 53.1 scores on a scale | Standard Deviation 28.72 |
| Control Arm | Forgotten Joint Score (FJS-12) | FJS at 1 year | 45.5 scores on a scale | Standard Deviation 33.59 |
| Control Arm | Forgotten Joint Score (FJS-12) | FJS at 12 Weeks | 26.4 scores on a scale | Standard Deviation 23.39 |
Comparison: Comparison of FJS at 12 weeksp-value: 0.0165t-test, 2 sided
Comparison: Comparison of FJS at 1 yearp-value: 0.1331t-test, 2 sided
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.
Time frame: 12 weeks, 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | Change from baseline at 1 year | 35.9 scores on a scale | Standard Deviation 18.93 |
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | Change from baseline at 12 weeks | 25.6 scores on a scale | Standard Deviation 21.03 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | Change from baseline at 1 year | 31.0 scores on a scale | Standard Deviation 23.21 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline | Change from baseline at 12 weeks | 24.3 scores on a scale | Standard Deviation 20.07 |
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 yearp-value: 0.1596t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeksp-value: 0.6834t-test, 2 sided
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.
Time frame: 12 weeks, 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | Change from baseline at 1 year | 37.5 scores on a scale | Standard Deviation 21.68 |
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | Change from baseline at 12 weeks | 24.9 scores on a scale | Standard Deviation 21.91 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | Change from baseline at 1 year | 35.3 scores on a scale | Standard Deviation 24.21 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline | Change from baseline at 12 weeks | 25.2 scores on a scale | Standard Deviation 23.14 |
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 yearp-value: 0.5675t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeksp-value: 0.924t-test, 2 sided
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.
Time frame: 12 weeks, 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | Change from Baseline at 1 year | 45.6 scores on a scale | Standard Deviation 23.67 |
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | Change from Baseline at 12 weeks | 33.4 scores on a scale | Standard Deviation 24.35 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | Change from Baseline at 1 year | 42.3 scores on a scale | Standard Deviation 31.42 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline | Change from Baseline at 12 weeks | 32.5 scores on a scale | Standard Deviation 26.28 |
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 yearp-value: 0.4636t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeksp-value: 0.8088t-test, 2 sided
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.
Time frame: 12 weeks, 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | Change from Baseline at 1 year | 39.5 scores on a scale | Standard Deviation 30.12 |
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | Change from Baseline at 12 weeks | 23.7 scores on a scale | Standard Deviation 40.87 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | Change from Baseline at 1 year | 38.1 scores on a scale | Standard Deviation 35.09 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline | Change from Baseline at 12 weeks | 23.9 scores on a scale | Standard Deviation 30.71 |
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 yearp-value: 0.8t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeksp-value: 0.973t-test, 2 sided
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.
Time frame: 12 weeks, 1 year
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | Change from baseline at 1 year | 31.1 scores on a scale | Standard Deviation 21.13 |
| Study Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | Change from baseline at 12 weeks | 20.4 scores on a scale | Standard Deviation 21.92 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | Change from baseline at 1 year | 28.4 scores on a scale | Standard Deviation 24.02 |
| Control Arm | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline | Change from baseline at 12 weeks | 21.8 scores on a scale | Standard Deviation 23.62 |
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 yearp-value: 0.4586t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeksp-value: 0.6951t-test, 2 sided
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.
Time frame: 12 Weeks
Population: Per Protocol Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Learning Curve | 2.2 Degrees | Standard Deviation 1.66 |
| Control Arm | Learning Curve | 2.4 Degrees | Standard Deviation 1.9 |
Comparison: Comparison between the accuracy achieved in the first 10 cases compared to the subsequent casesp-value: 0.6745t-test, 2 sided
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.
Time frame: 12 weeks, 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Pain - Change From Baseline | Pain at Rest Change from baseline at 1 year | -4.1 scores on a scale | Standard Deviation 2.93 |
| Study Arm | Pain - Change From Baseline | Pain at rest at 12 weeks | 2.3 scores on a scale | Standard Deviation 2.38 |
| Study Arm | Pain - Change From Baseline | Pain with activity change from baseline at 12 weeks | -4.3 scores on a scale | Standard Deviation 2.75 |
| Study Arm | Pain - Change From Baseline | Pain at Rest change from baseline at 12 weeks | -3.3 scores on a scale | Standard Deviation 3.18 |
| Study Arm | Pain - Change From Baseline | Pain with activity at 12 weeks | 2.9 scores on a scale | Standard Deviation 2.43 |
| Study Arm | Pain - Change From Baseline | Pain at rest at 1 year | 1.4 scores on a scale | Standard Deviation 2.14 |
| Study Arm | Pain - Change From Baseline | Pain with activity at 1 year | 1.9 scores on a scale | Standard Deviation 2.37 |
| Study Arm | Pain - Change From Baseline | Pain with activity change from baseline at 1 year | -5.2 scores on a scale | Standard Deviation 2.78 |
| Control Arm | Pain - Change From Baseline | Pain with activity at 1 year | 2.5 scores on a scale | Standard Deviation 2.58 |
| Control Arm | Pain - Change From Baseline | Pain at Rest Change from baseline at 1 year | -4.0 scores on a scale | Standard Deviation 2.71 |
| Control Arm | Pain - Change From Baseline | Pain at Rest change from baseline at 12 weeks | -2.9 scores on a scale | Standard Deviation 3.05 |
| Control Arm | Pain - Change From Baseline | Pain at rest at 12 weeks | 3.4 scores on a scale | Standard Deviation 2.75 |
| Control Arm | Pain - Change From Baseline | Pain at rest at 1 year | 2.1 scores on a scale | Standard Deviation 2.52 |
| Control Arm | Pain - Change From Baseline | Pain with activity change from baseline at 1 year | -5.0 scores on a scale | Standard Deviation 2.71 |
| Control Arm | Pain - Change From Baseline | Pain with activity change from baseline at 12 weeks | -4.0 scores on a scale | Standard Deviation 3 |
| Control Arm | Pain - Change From Baseline | Pain with activity at 12 weeks | 3.6 scores on a scale | Standard Deviation 2.81 |
Comparison: T-test P-value for difference in change from baseline for Pain at rest between ROBOTIC and MANUAL at 1 yearp-value: 0.8887t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline for pain at rest between ROBOTIC and MANUAL at 12 weeksp-value: 0.4007t-test, 2 sided
Comparison: T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for pain at rest at 12 weeksp-value: 0.0074t-test, 2 sided
Comparison: T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain at rest at 1 yearp-value: 0.0663t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for Pain with Activity at 1 yearp-value: 0.7096t-test, 2 sided
Comparison: T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for pain with activity at 12 weeksp-value: 0.5321t-test, 2 sided
Comparison: T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 12 weeksp-value: 0.0709t-test, 2 sided
Comparison: T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 1 yearp-value: 0.1274t-test, 2 sided
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
Time frame: 12 weeks, 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm | Subject Satisfaction With Knee Replacement | Satisfaction at 12 weeks | 1.3 scores on a scale | Standard Deviation 2.03 |
| Study Arm | Subject Satisfaction With Knee Replacement | Satisfaction at 1 year | 1.6 scores on a scale | Standard Deviation 2.73 |
| Control Arm | Subject Satisfaction With Knee Replacement | Satisfaction at 12 weeks | 1.6 scores on a scale | Standard Deviation 2.29 |
| Control Arm | Subject Satisfaction With Knee Replacement | Satisfaction at 1 year | 1.4 scores on a scale | Standard Deviation 2.73 |
Comparison: T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 12 weeksp-value: 0.4851t-test, 2 sided
Comparison: T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 1 yearp-value: 0.6486t-test, 2 sided