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

A Prospective, Multi-Center, Post-Market Clinical Study to Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System in Total Knee Arthroplasty Procedures.

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

Study Overview

• Status: Completed
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Device: CORI™ KNEE TENSIONER

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
  • Ohio
    • New Albany, Ohio, United States, 43054
      • Mount Carmel Research Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, Magee
  • Wisconsin
    • Ashland, Wisconsin, United States, 54806
      • Tamarack Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CORI™ KNEE TENSIONER; Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.	Gap planning measurements will be defined as the medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.	During surgical procedure

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): June 4, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Robotic; Total Knee Arthroplasty (TKA); CORI; CORI™ KNEE TENSIONER
• Other Study ID Numbers: CORI TENSIONER.2020.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No