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

December 18, 2023 updated by: Smith & Nephew, Inc.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
    • Ohio
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh, Magee
        • Contact:
        • Contact:
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Active, not recruiting
        • Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CORI TENSIONER
Subjects having a robotic TKA procedure with the 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
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months
Time Frame: 12 months
The VAS records the subject'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 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) pre-operative, 6 weeks, and 6 months
Time Frame: pre-operative, 6 weeks, and 6 months
The VAS records the subject'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 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.
pre-operative, 6 weeks, and 6 months
Quality of Life (EQ-5D-5L Index score)
Time Frame: Pre-operative, 6 weeks, 6 months, and 12 months

The EQ-5D-5L will be collected at the preoperative visit and at the 6-week, 6-month,& 12-month Follow-Up Visits.

The descriptive system is used to describe the subject's health state & consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
Pre-operative, 6 weeks, 6 months, and 12 months
2011 Knee Society Score (KSS)
Time Frame: Pre-operative, 6 weeks, 6 months, and 12 months

The 2011 KSS will be collected at the preoperative visit and at the 6-week, 6-month, and 12-month Follow-Up Visits.

The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales:

  1. An "Objective" Knee Score (seven items: 100 points)
  2. A Patient Satisfaction Score (five items: 40 points)
  3. A Patient Expectation Score (three items: 15 points)
  4. A Functional Knee Score (19 items: 100 points)

The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities. A higher number is a better outcome.
Pre-operative, 6 weeks, 6 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.
Time Frame: During surgical procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

April 30, 2026

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)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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