Trial Outcomes & Findings for Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty (NCT NCT04730271)

Last Updated: 2025-04-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-04-27

Participant Flow

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 An additional 34 subjects were recruited during the study but did not receive the planned treatment and were withdrawn and replaced in the study as allowed in the protocol.

Of the 34 subjects withdrawn without receiving the planned treatment, 8 were withdrawn due to a significant delay in having their procedure performed, 7 were withdrawn due to not meeting the inclusion/exclusion criteria, 6 were withdrawn due to the surgeon using an out of scope implant, 4 withdrew due to their insurance not covering surgery, 5 withdrew their consent, 3 were withdrawn due to the specified instrumentation not being available and one was withdrawn due to a change in the surgeon.

Participant milestones

Participant milestones
Measure	Study Arm Robotic-Assisted	Control Arm Manual Instrumentation
Overall Study STARTED	100	100
Overall Study Intent to Treat and Completed 12 Week Follow up Per Protocol	90	92
Overall Study COMPLETED	88	81
Overall Study NOT COMPLETED	12	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Arm Robotic-Assisted	Control Arm Manual Instrumentation
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	7	13
Overall Study Lost to Follow-up	3	3
Overall Study Death	1	0

Baseline Characteristics

Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm n=100 Knees Robotic-Assisted	Control Arm n=100 Knees Manual Instrumentation	Total n=200 Knees Total of all reporting groups
Age, Continuous	66.6 Years STANDARD_DEVIATION 8.28 • n=5 Participants	64.4 Years STANDARD_DEVIATION 9.05 • n=7 Participants	65.5 Years STANDARD_DEVIATION 8.72 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	53 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	47 Participants n=7 Participants	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	92 Participants n=7 Participants	189 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	26 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	68 Participants n=7 Participants	149 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	Study Arm n=90 Participants Robotic-Assisted	Control Arm n=92 Participants Manual Instrumentation
Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks.	2.2 Degrees Standard Deviation 1.77	2.5 Degrees Standard Deviation 1.76

SECONDARY outcome

Timeframe: 12 weeks

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	Study Arm n=74 Participants Robotic-Assisted	Control Arm n=85 Participants Manual Instrumentation
Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks.	1.4 Degrees Standard Deviation 1.16	2.0 Degrees Standard Deviation 1.49

SECONDARY outcome

Timeframe: 12 weeks

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	Study Arm n=80 Participants Robotic-Assisted	Control Arm n=91 Participants Manual Instrumentation
Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks	1.2 Degrees Standard Deviation 0.95	1.6 Degrees Standard Deviation 1.15

SECONDARY outcome

Timeframe: 12 weeks

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	Study Arm n=80 Participants Robotic-Assisted	Control Arm n=91 Participants Manual Instrumentation
Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks	1.9 Degrees Standard Deviation 1.42	2.8 Degrees Standard Deviation 1.89

SECONDARY outcome

Timeframe: 12 weeks

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	Study Arm n=80 Participants Robotic-Assisted	Control Arm n=91 Participants Manual Instrumentation
Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks	1.6 Degrees Standard Deviation 1.25	2.7 Degrees Standard Deviation 2.05

SECONDARY outcome

Timeframe: 12 weeks, 1 year

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Study Arm n=100 Participants Robotic-Assisted	Control Arm n=100 Participants Manual Instrumentation
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	29 Number of subjects
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	16 Number of subjects
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	27 Number of subjects
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	12 Number of subjects

SECONDARY outcome

Timeframe: Day of operation (intraoperative)

Population: Safety Set

Investigators conducted an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts.

Outcome measures

Outcome measures
Measure	Study Arm n=100 Participants Robotic-Assisted	Control Arm n=100 Participants Manual Instrumentation
Soft Tissue Damage Incidence of medial collateral ligament being compromised intraoperatively.	0 participants	2 participants
Soft Tissue Damage Incidence of lateral collateral ligament being compromised intraoperatively.	0 participants	0 participants
Soft Tissue Damage Incidence of posterior cruciate ligament being compromised intraoperatively	0 participants	1 participants
Soft Tissue Damage Incidence of posterior lateral capsule being compromised intraoperatively.	0 participants	0 participants
Soft Tissue Damage Incidence of posterior medial capsule being compromised intraoperatively.	0 participants	0 participants
Soft Tissue Damage Incidence of patella tendon being compromised intraoperatively.	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
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	0.20 scores on a scale Standard Deviation 0.195
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 0.170	0.16 scores on a scale Standard Deviation 0.186

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
Forgotten Joint Score (FJS-12) FJS at 12 Weeks	35.4 scores on a scale Standard Deviation 25.73	26.4 scores on a scale Standard Deviation 23.39
Forgotten Joint Score (FJS-12) FJS at 1 year	53.1 scores on a scale Standard Deviation 28.72	45.5 scores on a scale Standard Deviation 33.59

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
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	31.0 scores on a scale Standard Deviation 23.21
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	24.3 scores on a scale Standard Deviation 20.07

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks, 1 year

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
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	35.3 scores on a scale Standard Deviation 24.21
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	25.2 scores on a scale Standard Deviation 23.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks, 1 year

Population: Per Protocol Analysis Set

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
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	28.4 scores on a scale Standard Deviation 24.02
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	21.8 scores on a scale Standard Deviation 23.62

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks, 1 year

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
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	38.1 scores on a scale Standard Deviation 35.09
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	23.9 scores on a scale Standard Deviation 30.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks, 1 year

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
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	42.3 scores on a scale Standard Deviation 31.42
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	32.5 scores on a scale Standard Deviation 26.28

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
Subject Satisfaction With Knee Replacement Satisfaction at 12 weeks	1.3 scores on a scale Standard Deviation 2.03	1.6 scores on a scale Standard Deviation 2.29
Subject Satisfaction With Knee Replacement Satisfaction at 1 year	1.6 scores on a scale Standard Deviation 2.73	1.4 scores on a scale Standard Deviation 2.73

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Study Arm n=86 Participants Robotic-Assisted	Control Arm n=94 Participants Manual Instrumentation
Pain - Change From Baseline Pain at Rest Change from baseline at 1 year	-4.1 scores on a scale Standard Deviation 2.93	-4.0 scores on a scale Standard Deviation 2.71
Pain - Change From Baseline Pain at Rest change from baseline at 12 weeks	-3.3 scores on a scale Standard Deviation 3.18	-2.9 scores on a scale Standard Deviation 3.05
Pain - Change From Baseline Pain at rest at 12 weeks	2.3 scores on a scale Standard Deviation 2.38	3.4 scores on a scale Standard Deviation 2.75
Pain - Change From Baseline Pain at rest at 1 year	1.4 scores on a scale Standard Deviation 2.14	2.1 scores on a scale Standard Deviation 2.52
Pain - Change From Baseline Pain with activity change from baseline at 1 year	-5.2 scores on a scale Standard Deviation 2.78	-5.0 scores on a scale Standard Deviation 2.71
Pain - Change From Baseline Pain with activity change from baseline at 12 weeks	-4.3 scores on a scale Standard Deviation 2.75	-4.0 scores on a scale Standard Deviation 3.00
Pain - Change From Baseline Pain with activity at 12 weeks	2.9 scores on a scale Standard Deviation 2.43	3.6 scores on a scale Standard Deviation 2.81
Pain - Change From Baseline Pain with activity at 1 year	1.9 scores on a scale Standard Deviation 2.37	2.5 scores on a scale Standard Deviation 2.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: Per Protocol Analysis Set

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.

Outcome measures

Outcome measures
Measure	Study Arm n=41 Participants Robotic-Assisted	Control Arm n=44 Participants Manual Instrumentation
Learning Curve	2.2 Degrees Standard Deviation 1.66	2.4 Degrees Standard Deviation 1.90

Adverse Events

Study Arm

Serious events: 16 serious events

Other events: 32 other events

Deaths: 1 deaths

Control Arm

Serious events: 28 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Ian Leslie

DePuy Synthes

Phone: N/A

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Study Arm n=100 participants at risk Robotic-Assisted	Control Arm n=100 participants at risk Manual Instrumentation
Musculoskeletal and connective tissue disorders Arthrofibrosis	6.0% 6/100 • Number of events 7 • 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.	8.0% 8/100 • Number of events 9 • 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.
Infections and infestations Infection	0.00% 0/100 • 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.	2.0% 2/100 • Number of events 4 • 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.
Infections and infestations Post Procedural Infection	0.00% 0/100 • 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.	2.0% 2/100 • Number of events 3 • 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.
Infections and infestations Device Related Infection	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Infections and infestations Bursitis Infective	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Arthropathy disruption	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Tendon Disorder	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	4.0% 4/100 • Number of events 4 • 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.	6.0% 6/100 • Number of events 7 • 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.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Cardiac disorders Atrial Fibrillation	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Blood and lymphatic system disorders Febrileneutropenia	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Infections and infestations Systemic Mycosis	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Meniscus Injury	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Metabolism and nutrition disorders Hypovolaemia	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval Cancer	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Renal and urinary disorders Acute Kidney Injury	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonaryembolism	1.0% 1/100 • Number of events 1 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Ligament Injury	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.

Measure	Study Arm n=100 participants at risk Robotic-Assisted	Control Arm n=100 participants at risk Manual Instrumentation
Gastrointestinal disorders Nausea	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
General disorders Pain	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
General disorders Peripheral Swelling	1.0% 1/100 • Number of events 1 • 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.	1.0% 1/100 • Number of events 1 • 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.
General disorders Swelling	0.00% 0/100 • 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.	3.0% 3/100 • Number of events 3 • 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.
Infections and infestations Arthritis Infection	0.00% 0/100 • 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.	2.0% 2/100 • Number of events 2 • 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.
Injury, poisoning and procedural complications Contusion	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Use Error	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incision Site Pain	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 9/100 • Number of events 10 • 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.	6.0% 6/100 • Number of events 6 • 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.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/100 • 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.	2.0% 2/100 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Bone Pain	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Joint Noise	2.0% 2/100 • Number of events 2 • 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.	0.00% 0/100 • 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.
Musculoskeletal and connective tissue disorders Joint Range of Motion Decreased	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Musculoskeletal and connective tissue disorders Joint Stiffness	1.0% 1/100 • Number of events 1 • 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.	2.0% 2/100 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Joint Swelling	5.0% 5/100 • Number of events 5 • 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.	3.0% 3/100 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	2.0% 2/100 • Number of events 2 • 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.	2.0% 2/100 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Musculoskeletal and connective tissue disorders Tendonitis	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Nervous system disorders Hemiparesis	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Nervous system disorders Hypoaesthesia	2.0% 2/100 • Number of events 2 • 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.	0.00% 0/100 • 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.
Nervous system disorders Neuralgia	2.0% 2/100 • Number of events 2 • 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.	2.0% 2/100 • Number of events 2 • 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.
Product Issues Device Loosening	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Blister	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Skin Irritation	1.0% 1/100 • Number of events 1 • 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.	0.00% 0/100 • 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.
Skin and subcutaneous tissue disorders Skin Necrosis	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.
Injury, poisoning and procedural complications Ligament Injury	0.00% 0/100 • 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.	1.0% 1/100 • Number of events 1 • 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.