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

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

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

Key facts

Study ID

NCT04849884

Run by

Smith & Nephew, Inc.

People needed

77

Starts

2022-03-30

Expected to finish

2025-06-04

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States
• Mount Carmel Research Institute — New Albany, Ohio, United States
• University of Pittsburgh, Magee — Pittsburgh, Pennsylvania, United States
• Tamarack Health — Ashland, Wisconsin, United States

Full record on ClinicalTrials.gov

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