Study to Evaluate the REAL Intelligence Tensioner Accessory in Robotic Total Knee Arthroplasty Procedures

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    80
  • sponsor
    Smith & Nephew, Inc.
Updated on 23 March 2022

Summary

This is a prospective, multi-center, open-label study evaluating the performance of the REAL INTELLIGENCE™ Tensioner as an accessory to the CORI™ Surgical System at approximately 2 centers across the United States. Eighty patients who are eligible for a robotic TKA procedure with the CORI Surgical System will be followed for approximately 12 months.

The REAL INTELLIGENCE™ Tensioner is an accessory to REAL INTELLIGENCE™ CORI™ Surgical System. The Tensioner may be used to 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 Tensioner as an accessory to the CORI Surgical System by assessing patient satisfaction with the EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS).

Details
Condition Arthroplasty, Replacement, Knee
Treatment REAL INTELLIGENCE Tensioner
Clinical Study IdentifierNCT04849884
SponsorSmith & Nephew, Inc.
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject must provide written informed consent
Subject is 18 years or older
Willing and able to make all required study visits
Able to follow instructions and deemed capable of completing the KSS and EQ-5D-5L questionnaires
Subject is suitable for the CORI Surgical System
Subject requires a cemented TKA as a primary indication due to any of the following
condition
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

Contraindications or hypersensitivity to the use of the CORI Surgical System per the Instructions For Use (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 highly effective birth control measures
Subjects who are non-English speaking
Any subject that meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2011 Section 3.44
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
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
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