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

Smith & Nephew

Status

Active, not recruiting

Conditions

Arthroplasty

Knee

Replacement

Treatments

Device: CORI™ KNEE TENSIONER

Study type

Interventional

Funder types

Industry

Identifiers

NCT04849884

CORI TENSIONER.2020.04

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
Subject is eighteen (18) years old or older.
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).
Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
Subject is suitable for the CORI™ Surgical System.
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

Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the 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 birth control measures.
Subjects who are non-English speaking.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155.
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