Clinical trial NCT04849884: To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Keywords: Total Knee Arthroplasty (TKA)
Robotic
CORI™ KNEE TENSIONER
CORI
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) pre-operative, 6 weeks, and 6 months
timeFrame: pre-operative, 6 weeks, and 6 months
measure: Quality of Life (EQ-5D-5L Index score)
timeFrame: Pre-operative, 6 weeks, 6 months, and 12 months
measure: 2011 Knee Society Score (KSS)
timeFrame: Pre-operative, 6 weeks, 6 months, and 12 months
Other outcomes:
measure: Medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.
timeFrame: During surgical procedure
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Magee
state: Pennsylvania
city: Ashland
country: United States
facility: Memorial Medical Center
state: Wisconsin
Study officials:
References: