Trial Outcomes & Findings for To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. (NCT NCT04849884)
NCT ID: NCT04849884
Last Updated: 2026-06-30
Results Overview
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L VAS score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The EQ-5D-5L VAS score records the participant's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 0 to 100 where 0 is the worst imaginable health state and 100 is the best imaginable health state (i.e., a higher score was a better outcome).
COMPLETED
NA
77 participants
Baseline, 6 weeks, 6 months, 12 months
2026-06-30
Participant Flow
Participants were recruited across four investigational sites for approximately 15 months.
Participant milestones
| Measure |
CORI™ KNEE TENSIONER
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
CORI™ KNEE TENSIONER
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Screen Failure (intraoperative exclusion criterion during surgery and withdrawn post-procedure)
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Device deficiency
|
1
|
|
Overall Study
Device unavailable (returned to Sponsor)
|
1
|
|
Overall Study
CORI Robot failed Intraoperative
|
1
|
Baseline Characteristics
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
Baseline characteristics by cohort
| Measure |
CORI™ KNEE TENSIONER
n=77 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
Age, Continuous
|
65.31 years
STANDARD_DEVIATION 9.44 • n=20 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Body Mass Index (BMI)
|
29.53 kg/m^2
STANDARD_DEVIATION 4.66 • n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 6 months, 12 monthsPopulation: The Full Analysis Set (FAS) Population included all participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure at the time frame specified.
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L VAS score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The EQ-5D-5L VAS score records the participant's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 0 to 100 where 0 is the worst imaginable health state and 100 is the best imaginable health state (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
CORI™ KNEE TENSIONER
n=69 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 weeks
|
3 score on a scale
Standard Deviation 15
|
|
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 months
|
7 score on a scale
Standard Deviation 16
|
|
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 12 months
|
8 score on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, 12 monthsPopulation: The Full Analysis Set (FAS) Population included all participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure at the time frame specified.
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L Index score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) to create a combined Health Index Score. The combined Health Index Score is on a scale of 0 to 1 with a higher score indicating a better outcome.
Outcome measures
| Measure |
CORI™ KNEE TENSIONER
n=69 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Weeks
|
0.05 score on a scale
Standard Deviation 0.14
|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Months
|
0.14 score on a scale
Standard Deviation 0.15
|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 12 Months
|
0.16 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, 12 monthsPopulation: The Full Analysis Set (FAS) Population included participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure and time frame specified. Due to issues with data collection for the KSS Objective Score, data was missing for 15 participants at 6 weeks, 57 participants at 6 months, and 39 participants at 12 months. The limited KSS Objective data is reported as collected.
Change from baseline to 6 weeks, 6 months, and 12 months in the 2011 Knee Society Score (KSS) Objective Score. The KSS 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™ KNEE TENSIONER
n=55 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Weeks
|
20 score on a scale
Standard Deviation 19
|
|
2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Months
|
52 score on a scale
Standard Deviation 9
|
|
2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 12 Months
|
49 score on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, 12 monthsPopulation: The Full Analysis Set (FAS) Population included all participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure at the time frame specified.
Change from baseline to 6 weeks, 6 months, and 12 months in the 2011 Knee Society Score (KSS) Function Score. The KSS consists of 4 separate sub-scales. The Function Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. The Function Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
Outcome measures
| Measure |
CORI™ KNEE TENSIONER
n=65 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Weeks
|
7 score on a scale
Standard Deviation 20
|
|
2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Months
|
29 score on a scale
Standard Deviation 18
|
|
2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 12 Months
|
30 score on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, 12 monthsPopulation: The Full Analysis Set (FAS) Population included all participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure at the time frame specified.
Change from baseline to 6 weeks, 6 months, and 12 months in the 2011 Knee Society Score (KSS) Satisfaction Score. The KSS 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™ KNEE TENSIONER
n=70 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Weeks
|
10 score on a scale
Standard Deviation 9
|
|
2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 6 Months
|
17 score on a scale
Standard Deviation 9
|
|
2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from Baseline to 12 Months
|
17 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 6 months, 12 monthsPopulation: The Full Analysis Set (FAS) Population included all participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure at the time frame specified.
The 2011 Knee Society Score (KSS) 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™ KNEE TENSIONER
n=73 Participants
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months
Baseline
|
14.5 score on a scale
Standard Deviation 1.2
|
|
2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months
6 weeks
|
8.5 score on a scale
Standard Deviation 2.8
|
|
2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months
6 months
|
9.5 score on a scale
Standard Deviation 3.2
|
|
2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months
12 months
|
9.4 score on a scale
Standard Deviation 3.7
|
Adverse Events
CORI™ KNEE TENSIONER
Serious adverse events
| Measure |
CORI™ KNEE TENSIONER
n=77 participants at risk
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
Nervous system disorders
NEUROPATHY
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Eye disorders
VITREOUS HEMORRHAGE
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Injury, poisoning and procedural complications
DAMAGE TO LIGAMENT(S)
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
JOINT DISLOCATION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
|
9.1%
7/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
UNSPECIFIED MUSCULOSKELETAL PROBLEM
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER
|
2.6%
2/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Injury, poisoning and procedural complications
POST OPERATIVE WOUND INFECTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
Other adverse events
| Measure |
CORI™ KNEE TENSIONER
n=77 participants at risk
Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.
|
|---|---|
|
Nervous system disorders
SYNCOPE/FAINTING
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Nervous system disorders
MOVEMENT DISORDER
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Nervous system disorders
NERVE DAMAGE
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Nervous system disorders
NEUROPATHY
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Nervous system disorders
NUMBNESS
|
2.6%
2/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Nervous system disorders
SLEEP DYSFUNCTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Vascular disorders
HEMORRHAGE/BLEEDING
|
2.6%
2/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Eye disorders
UNSPECIFIED EYE / VISION PROBLEM
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Gastrointestinal disorders
DYSPHAGIA/ ODYNOPHAGIA
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Gastrointestinal disorders
PYROSIS/HEARTBURN
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Renal and urinary disorders
HEMATURIA
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.8%
6/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
FASCIITIS
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
LOSS OF RANGE OF MOTION
|
2.6%
2/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE/TENDON DAMAGE
|
2.6%
2/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
2.6%
2/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Injury, poisoning and procedural complications
SPINAL COLUMN INJURY
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Musculoskeletal and connective tissue disorders
UNSPECIFIED MUSCULOSKELETAL PROBLEM
|
3.9%
3/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Skin and subcutaneous tissue disorders
SKIN INFLAMMATION/ IRRITATION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Skin and subcutaneous tissue disorders
ABSCESS
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Infections and infestations
UNSPECIFIED INFECTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Infections and infestations
VIRAL INFECTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Injury, poisoning and procedural complications
BRUISE/CONTUSION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Injury, poisoning and procedural complications
FALL
|
6.5%
5/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
Injury, poisoning and procedural complications
POST OPERATIVE WOUND INFECTION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
General disorders
FATIGUE
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
General disorders
LOW BLOOD PRESSURE/ HYPOTENSION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
General disorders
INFLAMMATION
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
General disorders
PAIN
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
General disorders
SWELLING/ EDEMA
|
7.8%
6/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
|
General disorders
NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS
|
1.3%
1/77 • Adverse events were collected during surgery to study completion, approximately 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will be provided results communications no later than 90 days prior to public release for review \& can embargo communications regarding trial results for a period up to 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER