To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.

Smith & Nephew, Inc.77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthroplasty Replacement Knee

Interventions

CORI™ KNEE TENSIONERDEVICE

Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Hospital for Special Surgery

New York, New York, United States

Mount Carmel Research Institute

New Albany, Ohio, United States

University of Pittsburgh, Magee

Pittsburgh, Pennsylvania, United States

Tamarack Health

Ashland, Wisconsin, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, 6 weeks, 6 months, 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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