Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures (NCT NCT04797897)
NCT ID: NCT04797897
Last Updated: 2025-03-25
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.
TERMINATED
NA
4 participants
6 weeks
2025-03-25
Participant Flow
There were 4 participants enrolled \& randomized into the study with each contributing one study knee.
Participant milestones
| Measure |
CORI UKA
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
CORI UKA
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Overall Study
Study Termination by Sponsor
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
Baseline characteristics by cohort
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Overall number of participants analyzed included those enrolled in the study with data collected for the outcome and time frame specified. Leg alignment not collected for 1 participant in CORI UKA group, and target data was not collected for 1 participant in Conventional UKA group.
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.
Outcome measures
| Measure |
CORI UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Post-operative Leg Alignment
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and 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 in degrees was 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 UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Component Alignment: Femoral Antero-Posterior (A/P) Angle
|
97 degrees
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
95 degrees
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and 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 UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Component Alignment: Tibial Antero-Posterior (A/P) Angle
|
84 degrees
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
89 degrees
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and 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 UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Component Alignment: Total Antero-Posterior (A/P) Valgus Angle
|
181 degrees
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
184 degrees
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and 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 in degrees was 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 UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Component Alignment: Lateral View Femoral Flexion Angle
|
0 degrees
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
5 degrees
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and 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 in degrees was 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 UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Component Alignment: Lateral View Tibial Angle
|
86 degrees
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
85.5 degrees
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Overall number of participants analyzed indicated those enrolled in the study with data collected for the outcome and time frame specified. Data was not collected for 2 participants due to the early termination of the study.
Radiographic assessment measured by number of participants with any radiographic finds on antero-posterior (A/P) and lateral (L) views (yes/no). Radiographic findings indicated the presence of radiolucent lines, osteolysis \& implant migration.
Outcome measures
| Measure |
CORI UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=1 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Radiographic Assessment
No
|
1 Participants
|
1 Participants
|
|
Radiographic Assessment
Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The 2011 Knee Society Score consists of 4 separate sub-scales. The "Objective" Knee Score is seven items with a range of 0 to 100, with a higher score indicating a better outcome.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
2011 Knee Society Score (KSS): Objective Knee Score
Baseline
|
49 score on a scale
Standard Deviation 32.53
|
33.5 score on a scale
Standard Deviation 3.54
|
|
2011 Knee Society Score (KSS): Objective Knee Score
6 weeks
|
62.5 score on a scale
Standard Deviation 4.95
|
57 score on a scale
Standard Deviation 7.07
|
|
2011 Knee Society Score (KSS): Objective Knee Score
6 months
|
61.5 score on a scale
Standard Deviation 4.95
|
50.5 score on a scale
Standard Deviation 17.68
|
|
2011 Knee Society Score (KSS): Objective Knee Score
12 months
|
70 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
49 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Satisfaction Score is five items with a range of 0 to 40, with a higher score indicating a better outcome.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
2011 Knee Society Score (KSS): Satisfaction Knee Score
Baseline
|
19 score on a scale
Standard Deviation 1.41
|
10 score on a scale
Standard Deviation 2.83
|
|
2011 Knee Society Score (KSS): Satisfaction Knee Score
6 weeks
|
24 score on a scale
Standard Deviation 0
|
23 score on a scale
Standard Deviation 4.24
|
|
2011 Knee Society Score (KSS): Satisfaction Knee Score
6 months
|
28 score on a scale
Standard Deviation 2.83
|
26 score on a scale
Standard Deviation 2.83
|
|
2011 Knee Society Score (KSS): Satisfaction Knee Score
12 months
|
34 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
30 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Expectation Score is three items with a range of 0 to 15, with a higher score indicating a better outcome. The Expectation score indicates the patient's opinion on the extent they expect the operation to improve their knee pain, and ability to perform activities of daily living and recreational activities.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
2011 Knee Society Score (KSS): Expectation Score
Baseline
|
13 score on a scale
Standard Deviation 1.41
|
11 score on a scale
Standard Deviation 1.41
|
|
2011 Knee Society Score (KSS): Expectation Score
6 weeks
|
9.5 score on a scale
Standard Deviation 3.54
|
8.5 score on a scale
Standard Deviation 3.54
|
|
2011 Knee Society Score (KSS): Expectation Score
6 months
|
11 score on a scale
Standard Deviation 5.66
|
10 score on a scale
Standard Deviation 1.41
|
|
2011 Knee Society Score (KSS): Expectation Score
12 months
|
8 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
9 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The 2011 Knee Society Score consists of 4 separate sub-scales. The Functional Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. Functional Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
2011 Knee Society Score (KSS): Functional Score
Baseline
|
30 score on a scale
Standard Deviation 11.31
|
35.5 score on a scale
Standard Deviation 4.95
|
|
2011 Knee Society Score (KSS): Functional Score
6 weeks
|
37.5 score on a scale
Standard Deviation 16.26
|
52 score on a scale
Standard Deviation 19.80
|
|
2011 Knee Society Score (KSS): Functional Score
6 months
|
59 score on a scale
Standard Deviation 7.07
|
72.5 score on a scale
Standard Deviation 2.12
|
|
2011 Knee Society Score (KSS): Functional Score
12 months
|
60 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
83 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to assess perceived function and pain answered on a Likert scale. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Oxford Knee Score (OKS)
Baseline
|
22.5 score on a scale
Standard Deviation 0.71
|
18.5 score on a scale
Standard Deviation 3.54
|
|
Oxford Knee Score (OKS)
6 weeks
|
16 score on a scale
Standard Deviation 2.83
|
29.5 score on a scale
Standard Deviation 2.12
|
|
Oxford Knee Score (OKS)
6 months
|
35.5 score on a scale
Standard Deviation 0.71
|
35 score on a scale
Standard Deviation 8.49
|
|
Oxford Knee Score (OKS)
12 months
|
38 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
41 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Forgotten Joint Score (FJS)
6 weeks
|
13.54 score on a scale
Standard Deviation 10.31
|
29.17 score on a scale
Standard Deviation 11.79
|
|
Forgotten Joint Score (FJS)
6 months
|
52.08 score on a scale
Standard Deviation 8.84
|
67.71 score on a scale
Standard Deviation 1.47
|
|
Forgotten Joint Score (FJS)
12 months
|
18.75 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
87.5 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
Baseline
|
0.71 score on a scale
Standard Deviation 0.03
|
0.58 score on a scale
Standard Deviation 0.01
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
6 weeks
|
0.69 score on a scale
Standard Deviation 0.13
|
0.79 score on a scale
Standard Deviation 0.01
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
6 months
|
0.81 score on a scale
Standard Deviation 0.02
|
0.83 score on a scale
Standard Deviation 0.04
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
12 months
|
0.80 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
0.77 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, and 12 monthsPopulation: Overall number of participants analyzed included those enrolled with data collected for the outcome and time frame specified.
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'.
Outcome measures
| Measure |
CORI UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 Participants
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score
6 weeks
|
72.5 score on a scale
Standard Deviation 10.61
|
72.5 score on a scale
Standard Deviation 10.61
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score
6 months
|
85 score on a scale
Standard Deviation 7.07
|
72.5 score on a scale
Standard Deviation 17.68
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score
12 months
|
80 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
75 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
|
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score
Baseline
|
67.5 score on a scale
Standard Deviation 17.68
|
55 score on a scale
Standard Deviation 7.07
|
Adverse Events
CORI UKA
Conventional UKA
Serious adverse events
| Measure |
CORI UKA
n=2 participants at risk
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 participants at risk
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
BROKEN ANKLE
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
INCREASED PAIN AND SWELLING IN RIGHT LEG
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
BILATERAL PULMONARY EMBOLISM (PE) & DEEP VEIN THROMBOSIS (DVT)
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
Other adverse events
| Measure |
CORI UKA
n=2 participants at risk
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
CORI: unicondylar knee arthroplasty (UKA) treated with CORI
|
Conventional UKA
n=2 participants at risk
Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Conventional: unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN KNEE, PREPATELLAR SWELLING
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
|
General disorders
BURNING AND ALTERED SENSATION AROUND LATERAL ASPECT OF SURGICAL WOUND.
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
|
Nervous system disorders
POSSIBLE PARKINSON'S
|
0.00%
0/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
50.0%
1/2 • Adverse events were collected from procedure to study termination, approximately 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 40 days but less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor may request removal of specified Confidential Information (other than results of the study) to the communication as is reasonably required to protect the Intellectual Property of the sponsor and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER