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To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CORI™ KNEE TENSIONER | Experimental | Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORI™ KNEE TENSIONER | Device | Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, 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). | Baseline, 6 weeks, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 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. |
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Inclusion Criteria:
Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
Subject is eighteen (18) years old or older.
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).
Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
Subject is suitable for the CORI™ Surgical System.
Subject requires a cemented TKA as a primary indication due to any of the following conditions:
Exclusion Criteria:
Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU.
Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study.
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures.
Subjects who are non-English speaking.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155.
Subjects who have participated previously in this clinical trial
Subjects with a history of poor compliance with medical treatment.
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).
Subject has been diagnosed with post-traumatic arthritis
Subject needs a bilateral TKA.
Subject has active infection or sepsis (treated or untreated)
Subject is morbidly obese with a body mass index (BMI) greater than 40.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. This includes:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States | ||
| Mount Carmel Research Institute |
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Participants were recruited across four investigational sites for approximately 15 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The Safety (SAF) Population included all participants that received the study device with data collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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, 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months, 12 months |
|
Adverse events were collected during surgery to study completion, approximately 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUROPATHY | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SYNCOPE/FAINTING | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | 1-800-821-5700 | datasharing.gcs@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 5, 2025 | Apr 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2025 | Apr 20, 2026 | SAP_001.pdf |
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| Baseline, 6 weeks, 6 months, 12 months |
| 2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 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. | Baseline, 6 weeks, 6 months, 12 months |
| 2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 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. | Baseline, 6 weeks, 6 months, 12 months |
| 2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 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. | Baseline, 6 weeks, 6 months, 12 months |
| 2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 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. | Baseline, 6 weeks, 6 months, 12 months |
| New Albany |
| Ohio |
| 43054 |
| United States |
| University of Pittsburgh, Magee | Pittsburgh | Pennsylvania | 15213 | United States |
| Tamarack Health | Ashland | Wisconsin | 54806 | United States |
| Withdrawal by Subject |
|
| Device deficiency |
|
| Device unavailable (returned to Sponsor) |
|
| CORI Robot failed Intraoperative |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG000 |
| 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. |
|
|
| Secondary | 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, 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months, 12 months |
|
|
|
| Secondary | 2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months, 12 months |
|
|
|
| Secondary | 2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months, 12 months |
|
|
|
| Secondary | 2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months, 12 months |
|
|
|
| Secondary | 2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months, 12 months |
|
|
|
| 0 |
| 77 |
| 17 |
| 77 |
| 25 |
| 77 |
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
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| VITREOUS HEMORRHAGE | Eye disorders | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| DAMAGE TO LIGAMENT(S) | Injury, poisoning and procedural complications | Systematic Assessment |
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| JOINT DISLOCATION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| LOSS OF RANGE OF MOTION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| UNSPECIFIED MUSCULOSKELETAL PROBLEM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| POST OPERATIVE WOUND INFECTION | Injury, poisoning and procedural complications | Systematic Assessment |
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| MOVEMENT DISORDER | Nervous system disorders | Systematic Assessment |
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| NERVE DAMAGE | Nervous system disorders | Systematic Assessment |
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| NEUROPATHY | Nervous system disorders | Systematic Assessment |
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| NUMBNESS | Nervous system disorders | Systematic Assessment |
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| SLEEP DYSFUNCTION | Nervous system disorders | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
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| HEMORRHAGE/BLEEDING | Vascular disorders | Systematic Assessment |
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| DYSPNEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| UNSPECIFIED EYE / VISION PROBLEM | Eye disorders | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment |
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| DYSPHAGIA/ ODYNOPHAGIA | Gastrointestinal disorders | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| PYROSIS/HEARTBURN | Gastrointestinal disorders | Systematic Assessment |
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| HEMATURIA | Renal and urinary disorders | Systematic Assessment |
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| URINARY TRACT INFECTION | Renal and urinary disorders | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| FASCIITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| LOSS OF RANGE OF MOTION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MUSCLE/TENDON DAMAGE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| SPINAL COLUMN INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| UNSPECIFIED MUSCULOSKELETAL PROBLEM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| SKIN INFLAMMATION/ IRRITATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| ABSCESS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| UNSPECIFIED INFECTION | Infections and infestations | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | Systematic Assessment |
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| BRUISE/CONTUSION | Injury, poisoning and procedural complications | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | Systematic Assessment |
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| POST OPERATIVE WOUND INFECTION | Injury, poisoning and procedural complications | Systematic Assessment |
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| FATIGUE | General disorders | Systematic Assessment |
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| LOW BLOOD PRESSURE/ HYPOTENSION | General disorders | Systematic Assessment |
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| INFLAMMATION | General disorders | Systematic Assessment |
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| PAIN | General disorders | Systematic Assessment |
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| SWELLING/ EDEMA | General disorders | Systematic Assessment |
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| NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS | General disorders | Systematic Assessment |
|
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.
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| Change from Baseline to 12 Months |
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| Change from Baseline to 12 Months |
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| Change from Baseline to 12 Months |
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| Change from Baseline to 12 Months |
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| 6 months |
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| 12 months |
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