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

NCT ID: NCT04849884

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2026-04-30

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.

Conditions

Arthroplasty; Replacement; Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CORI TENSIONER

Subjects having a robotic TKA procedure with the CORI Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.

Group Type: EXPERIMENTAL

CORI™ KNEE TENSIONER

Intervention Type: DEVICE

Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.

Interventions

CORI™ KNEE TENSIONER

Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital for Special Surgery

New York, New York, United States

OrthoNeuro

New Albany, Ohio, United States

University of Pittsburgh, Magee

Pittsburgh, Pennsylvania, United States

Memorial Medical Center

Ashland, Wisconsin, United States

Countries

United States

Other Identifiers

CORI TENSIONER.2020.04

Identifier Type: -

Identifier Source: org_study_id