Arthroplasty, Knee, Replacement
Conditions
Keywords
Total Knee Arthroplasty (TKA), Robotic, CORI™ KNEE TENSIONER, CORI
Brief summary
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
Detailed description
This is a post-market, prospective, multicenter, open-label study evaluating the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System at approximately 4 centers across the United States. Ninety (90) patients eligible for a robotic-assisted TKA procedure with the CORI™ Surgical System will be followed for approximately 12 months. The CORI™ KNEE TENSIONER is an accessory to REAL INTELLIGENCE™ CORI™ Surgical System. The TENSIONER may assist the surgeon in providing consistent varus and valgus stress during gap assessment before making any bony resections. The TENSIONER communicates directly with CORI software, providing automated data collection. The primary objective is to evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System by assessing patient satisfaction with the EQ-5D-5L VAS.
Interventions
DEVICECORI™ KNEE TENSIONER
Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF. 2. Subject is eighteen (18) years old or older. 3. Subject is willing and able to attend all study follow-up visits for up to one (1) year postoperatively (as defined in the study protocol and ICF). 4. Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs). 5. Subject is suitable for the CORI™ Surgical System. 6. Subject requires a cemented TKA as a primary indication due to any of the following conditions: * Degenerative joint disease, including osteoarthritis * Rheumatoid arthritis. * Avascular necrosis. * Requires correction of functional deformity * Requires treatment of fractures that were unmanageable using other techniques.
Exclusion criteria
1. Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU. 2. Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study. 3. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures. 4. Subjects who are non-English speaking. 5. Any subject that meets the definition of a Vulnerable Subject per ISO 14155. 6. Subjects who have participated previously in this clinical trial 7. Subjects with a history of poor compliance with medical treatment. 8. Subject needs a CORI™ Surgical System TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard TKA (e.g., stems, augments, or custom-made devices). 9. Subject has been diagnosed with post-traumatic arthritis 10. Subject needs a bilateral TKA. 11. Subject has active infection or sepsis (treated or untreated) 12. Subject is morbidly obese with a body mass index (BMI) greater than 40. 13. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. This includes: * Advanced osteoarthritis * Joint disease * Paget's or Charcot's disease * Vascular insufficiency * Muscular atrophy * Uncontrolled diabetes * Moderate to severe renal insufficiency * Neuromuscular disease * Mental illness or mental retardation * Drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months | Baseline, 6 weeks, 6 months, 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months | Baseline, 6 weeks, 6 months, 12 months | 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. |
| 2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months | Baseline, 6 weeks, 6 months, 12 months | 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. |
| 2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months | Baseline, 6 weeks, 6 months, 12 months | 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. |
| 2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months | Baseline, 6 weeks, 6 months, 12 months | 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. |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months | Baseline, 6 weeks, 6 months, 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited across four investigational sites for approximately 15 months.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.31 years STANDARD_DEVIATION 9.44 |
| Body Mass Index (BMI) | 29.53 kg/m^2 STANDARD_DEVIATION 4.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 77 |
| other Total, other adverse events | 25 / 77 |
| serious Total, serious adverse events | 17 / 77 |
Outcome results
None listed