Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures (NCT NCT04786119)
NCT ID: NCT04786119
Last Updated: 2025-10-31
Results Overview
The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-10-31
Participant Flow
Participants recruited across 8 sites in Europe, United Kingdom, India, and the United States.
Unit of analysis: knees
Participant milestones
| Measure |
CORI™ in Unicondylar Knee Arthroplasty (UKA)
Participants having robotic assisted unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: UKA with robotics assisted surgery using the CORI™ Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Overall Study
STARTED
|
55 55
|
71 71
|
|
Overall Study
COMPLETED
|
45 45
|
61 61
|
|
Overall Study
NOT COMPLETED
|
10 10
|
10 10
|
Reasons for withdrawal
| Measure |
CORI™ in Unicondylar Knee Arthroplasty (UKA)
Participants having robotic assisted unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: UKA with robotics assisted surgery using the CORI™ Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Subject withdrawn due to exclusion criteria (bilateral knee)
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures
Baseline characteristics by cohort
| Measure |
CORI™ in Unicondylar Knee Arthroplasty (UKA)
n=55 Participants
Participants having robotic assisted unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: UKA with robotics assisted surgery using the CORI™ Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=71 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White Caucasian
|
51 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or Arican American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian Indian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Filipino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Korean
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Vietnamese
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Height
|
168.6 centimeters (cm)
STANDARD_DEVIATION 11.0 • n=5 Participants
|
170.2 centimeters (cm)
STANDARD_DEVIATION 10.4 • n=7 Participants
|
169.5 centimeters (cm)
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Weight
|
86.4 kilograms (kg)
STANDARD_DEVIATION 16.6 • n=5 Participants
|
87.7 kilograms (kg)
STANDARD_DEVIATION 16.9 • n=7 Participants
|
87.1 kilograms (kg)
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Body Mass Index (BMI)
Underweight (BMI < 18.5)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Healthy weight (BMI 18.5 to < 25)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Overweight (BMI 25 to < 30)
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Class 1 obesity (BMI 30 to < 35)
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Class 2 obesity (BMI 35 to <40)
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Class 3 obesity (BMI 40 or over)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Primary Diagnosis
Osteoarthritis
|
55 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Primary Diagnosis
Rheumatoid arthritis
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Full analysis set included participants with at least one post-operative assessment up to the primary completion date with data collected for the time frame, procedure type, and outcome indicated.
The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
Outcome measures
| Measure |
CORI Robotics
n=109 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Post-Operative Leg Alignment
Overall
|
97 Participants
|
—
|
|
Post-Operative Leg Alignment
Unicondylar Knee Arthroplasty (UKA)
|
42 Participants
|
—
|
|
Post-Operative Leg Alignment
Total Knee Arthroplasty (TKA)
|
55 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Full analysis set included participants with at least one post-operative assessment up to the primary completion date with data collected for the time frame, procedure type, and outcome indicated.
The percentage of knees achieving post-operative leg alignment taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Percentage of knees achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
Outcome measures
| Measure |
CORI Robotics
n=109 knees
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Percentage of Knees Achieving Post-Operative Leg Alignment
Unicondylar Knee Arthroplasty (UKA)
|
89.36 percentage of knees
Interval 76.9 to 96.45
|
—
|
|
Percentage of Knees Achieving Post-Operative Leg Alignment
Total Knee Arthroplasty (TKA)
|
88.71 percentage of knees
Interval 78.11 to 95.34
|
—
|
|
Percentage of Knees Achieving Post-Operative Leg Alignment
Overall
|
88.99 percentage of knees
Interval 81.56 to 94.18
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the femoral flexion angle is to be obtained using standard radiographic tools. Femoral flexion angle is defined as the angle formed between a line across the base of the femoral condyles and a line that is centered along the femoral canal.
Outcome measures
| Measure |
CORI Robotics
n=47 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=64 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Component Alignment: Femoral Antero-Posterior (A/P) Angle
|
94.0 degrees
Standard Deviation 4.5
|
92.4 degrees
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the tibial angle denotes the angle formed on the medial side of the knee from intersecting lines parallel to the tibial base plate and a line drawn parallel to the tibial canal.
Outcome measures
| Measure |
CORI Robotics
n=47 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=64 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Component Alignment: Tibial Antero-Posterior (A/P) Angle
|
88.6 degrees
Standard Deviation 2.9
|
89.5 degrees
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The total valgus angle is the sum of the femoral flexion angle and the tibial angle.
Outcome measures
| Measure |
CORI Robotics
n=47 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=64 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Component Alignment: Total Valgus Angle
|
182.6 degrees
Standard Deviation 6.0
|
181.9 degrees
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view femoral flexion angle is obtained from the intersection of a line from the center of the femoral implant to the top of the femur with a line through the femoral canal. The angle is measured on the proximal side of the intersection.
Outcome measures
| Measure |
CORI Robotics
n=45 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=63 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Component Alignment: Femoral Flexion Angle
|
3.4 degrees
Standard Deviation 4.1
|
3.3 degrees
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view tibial angle is the angle obtained from the intersection of a line drawn parallel to the bottom of the tibial base insert and a line through the center of the tibial base and the tibial canal.
Outcome measures
| Measure |
CORI Robotics
n=45 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=63 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Component Alignment: Tibial Lateral Angle
|
84.6 degrees
Standard Deviation 12.9
|
83.8 degrees
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
Radiographic assessment on antero-posterior (A/P) and lateral (L) views were performed to identify radiographic findings for the presence of radiolucent lines, osteolysis and implant migration. The number of participants with radiographic findings were categorized as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
CORI Robotics
n=45 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=61 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Radiographic Assessment: Radiographic Findings
No
|
42 Participants
|
56 Participants
|
|
Radiographic Assessment: Radiographic Findings
Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Radiographic Findings
Missing
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The 2011 Knee Society Score Objective score is completed by the surgeon and assesses the condition of the knee based on factors like pain, alignment, ligament stability, and range of motion. The Objective score ranges from 0 to 100, with a higher score indicating better knee function (i.e., a better outcome).
Outcome measures
| Measure |
CORI Robotics
n=54 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=61 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
2011 Knee Society Score (KSS): Objective Score
Pre-Op
|
20.9 score on a scale
Standard Deviation 15.8
|
19.3 score on a scale
Standard Deviation 15.7
|
|
2011 Knee Society Score (KSS): Objective Score
6 weeks
|
44.7 score on a scale
Standard Deviation 18.9
|
44.1 score on a scale
Standard Deviation 18.2
|
|
2011 Knee Society Score (KSS): Objective Score
6 months
|
51.9 score on a scale
Standard Deviation 18.8
|
46.5 score on a scale
Standard Deviation 16.4
|
|
2011 Knee Society Score (KSS): Objective Score
12 months
|
51.9 score on a scale
Standard Deviation 18.9
|
46.5 score on a scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The 2011 Knee Society Score Function assesses the participant's ability to perform daily activities and is a component of the overall KSS evaluation. The Function score ranges from 0 to 100, with a higher score indicating better function (i.e., a better outcome).
Outcome measures
| Measure |
CORI Robotics
n=32 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=37 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
2011 Knee Society Score (KSS): Function Score
Pre-Op
|
43.6 score on a scale
Standard Deviation 10.9
|
45.0 score on a scale
Standard Deviation 11.3
|
|
2011 Knee Society Score (KSS): Function Score
6 weeks
|
59.0 score on a scale
Standard Deviation 13.5
|
54.1 score on a scale
Standard Deviation 15.7
|
|
2011 Knee Society Score (KSS): Function Score
6 months
|
66.5 score on a scale
Standard Deviation 13.9
|
65.9 score on a scale
Standard Deviation 12.8
|
|
2011 Knee Society Score (KSS): Function Score
12 months
|
73.7 score on a scale
Standard Deviation 9.0
|
69.2 score on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The 2011 Knee Society Score Satisfaction score is a five question 40-point scale completed by the participant. The Satisfaction score ranges from 0 to 40, with a higher score indicating greater satisfaction (i.e., a better outcome).
Outcome measures
| Measure |
CORI Robotics
n=55 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=71 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
2011 Knee Society Score (KSS): Satisfaction Score
Pre-Op
|
13.8 score on a scale
Standard Deviation 6.9
|
12.8 score on a scale
Standard Deviation 7.1
|
|
2011 Knee Society Score (KSS): Satisfaction Score
6 weeks
|
25.6 score on a scale
Standard Deviation 8.0
|
23.7 score on a scale
Standard Deviation 7.7
|
|
2011 Knee Society Score (KSS): Satisfaction Score
6 months
|
31.0 score on a scale
Standard Deviation 9.5
|
29.5 score on a scale
Standard Deviation 9.2
|
|
2011 Knee Society Score (KSS): Satisfaction Score
12 months
|
33.9 score on a scale
Standard Deviation 7.7
|
30.5 score on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The Oxford Knee Score (OKS) specifically assesses the patient's perspective following knee arthroplasty surgery to indicate knee function. Total overall scores range from 0 to 48. A score of 0 is the worst possible outcome while a score of 48 indicates the best possible outcome.
Outcome measures
| Measure |
CORI Robotics
n=55 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=71 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Oxford Knee Score (OKS)
Pre-op
|
23.2 score on a scale
Standard Deviation 7.5
|
21.8 score on a scale
Standard Deviation 7.8
|
|
Oxford Knee Score (OKS)
6 weeks
|
30.6 score on a scale
Standard Deviation 7.9
|
27.0 score on a scale
Standard Deviation 7.2
|
|
Oxford Knee Score (OKS)
6 months
|
39.3 score on a scale
Standard Deviation 8.5
|
37.0 score on a scale
Standard Deviation 8.4
|
|
Oxford Knee Score (OKS)
12 months
|
41.8 score on a scale
Standard Deviation 7.5
|
38.4 score on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The forgotten Joint Score (FJS) consisted of 12 questions with responses recorded using a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores were summed and linearly transformed to a 0 to 100 scale and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome (i.e., a high score indicated a better outcome).
Outcome measures
| Measure |
CORI Robotics
n=47 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=62 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Forgotten Joint Score (FJS)
6 weeks
|
35.0 score on a scale
Standard Deviation 26.6
|
27.5 score on a scale
Standard Deviation 24.4
|
|
Forgotten Joint Score (FJS)
6 months
|
57.7 score on a scale
Standard Deviation 32.4
|
46.0 score on a scale
Standard Deviation 31.8
|
|
Forgotten Joint Score (FJS)
12 months
|
68.0 score on a scale
Standard Deviation 27.9
|
51.2 score on a scale
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score uses a scale from 0 to 100, with 0 indicating 'the worst health you can imagine' (i.e., a worse outcome) and 100 indicating 'the best health you can imagine' (i.e., a better outcome).
Outcome measures
| Measure |
CORI Robotics
n=55 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=67 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Pre-op
|
69.2 score on a scale
Standard Deviation 18.27
|
66.27 score on a scale
Standard Deviation 19.48
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score
6 weeks
|
77.04 score on a scale
Standard Deviation 18.37
|
76.13 score on a scale
Standard Deviation 18.24
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score
6 months
|
79.08 score on a scale
Standard Deviation 16.81
|
78.75 score on a scale
Standard Deviation 16.94
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score
12 months
|
84.27 score on a scale
Standard Deviation 13.76
|
81.0 score on a scale
Standard Deviation 15.25
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months and 12 monthsPopulation: Full analysis set (FAS) included enrolled participants that had at least one post-operative assessment with data collected for the time frame specified.
The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., index score) and the EQ Visual Analogue scale (EQ VAS). The descriptive system is a health-related quality of life score that comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. A score of 1 indicates perfect health-related quality of life and 0 indicates no health-related quality of life (i.e., a higher score is a better outcome). Index scores cannot be greater than 1 but could be less than 0.
Outcome measures
| Measure |
CORI Robotics
n=55 Participants
Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.
CORI Robotics: Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=67 Participants
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score
Pre-op
|
0.63 score on a scale
Standard Deviation 0.19
|
0.58 score on a scale
Standard Deviation 0.21
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score
6 weeks
|
0.79 score on a scale
Standard Deviation 0.13
|
0.75 score on a scale
Standard Deviation 0.14
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score
6 months
|
0.84 score on a scale
Standard Deviation 0.14
|
0.82 score on a scale
Standard Deviation 0.12
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score
12 months
|
0.88 score on a scale
Standard Deviation 0.12
|
0.85 score on a scale
Standard Deviation 0.12
|
Adverse Events
CORI™ in Unicondylar Knee Arthroplasty (UKA)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
CORI™ in Total Knee Arthroplasty (TKA)
Serious events: 10 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CORI™ in Unicondylar Knee Arthroplasty (UKA)
n=55 participants at risk
Participants having robotic assisted unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: UKA with robotics assisted surgery using the CORI™ Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=71 participants at risk
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Gastrointestinal disorders
UNSPECIFIED GASTROINTESTINAL PROBLEM
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC COMPRESSION OR PROTRUSION
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
4.2%
3/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
JOINT CONTRACTURE
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
General disorders
FIBROSIS
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
2.8%
2/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
Other adverse events
| Measure |
CORI™ in Unicondylar Knee Arthroplasty (UKA)
n=55 participants at risk
Participants having robotic assisted unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: UKA with robotics assisted surgery using the CORI™ Robotics System.
|
CORI™ in Total Knee Arthroplasty (TKA)
n=71 participants at risk
Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics.
CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.
|
|---|---|---|
|
Nervous system disorders
NERVOUS SYSTEM INJURY
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
0.00%
0/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Nervous system disorders
NUMBNESS
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Nervous system disorders
PERIPHERAL NERVOUS INJURY
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Gastrointestinal disorders
UNSPECIFIED GASTROINTESTINAL PROBLEM
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
0.00%
0/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
4.2%
3/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
JOINT LAXITY
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
0.00%
0/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
UNSPECIFIED MUSCULOSKELETAL PROBLEM
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
NODULE
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BACTERIAL INFECTION
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
0.00%
0/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Infections and infestations
UNSPECIFIED INFECTION
|
1.8%
1/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
0.00%
0/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Infections and infestations
FALL
|
5.5%
3/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
2.8%
2/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Injury, poisoning and procedural complications
AMBULATION DIFFICULTIES
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
Musculoskeletal and connective tissue disorders
INFLAMMATION
|
0.00%
0/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
1.4%
1/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
General disorders
PAIN
|
12.7%
7/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
9.9%
7/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
|
General disorders
SWELLING/ EDEMA
|
3.6%
2/55 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
7.0%
5/71 • Adverse Events were collected from time of enrollment to study completion, approximately 12 months.
The Safety Population (SAF) included enrolled participants that were treated for UKA or TKA using CORI™ Robotics with data collected.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
Phone: +44 7811 407089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60