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

NCT04849884 | Active Not Recruiting FDA Device

• 1 other identifier: CORI TENSIONER.2020.04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Knee; Arthroplasty; Replacement

Keywords

Total Knee Arthroplasty (TKA); Robotic; CORI™ KNEE TENSIONER; CORI

Outcome Measures

Primary Outcomes (1)

• Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months

  The VAS records the subject's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.

  12 months

Secondary Outcomes (3)

• Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) pre-operative, 6 weeks, and 6 months

  pre-operative, 6 weeks, and 6 months

• Quality of Life (EQ-5D-5L Index score)

  Pre-operative, 6 weeks, 6 months, and 12 months

• 2011 Knee Society Score (KSS)

  Pre-operative, 6 weeks, 6 months, and 12 months

Other Outcomes (1)

• Medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.

  During surgical procedure

Study Arms (1)

CORI TENSIONER

EXPERIMENTAL

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

Device: CORI™ KNEE TENSIONER

Interventions

CORI™ KNEE TENSIONER DEVICE

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

CORI TENSIONER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (4)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

OrthoNeuro

New Albany, Ohio, 43054, United States

Location

University of Pittsburgh, Magee

Pittsburgh, Pennsylvania, 15213, United States

Location

Memorial Medical Center

Ashland, Wisconsin, 54806, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: February 10, 2022
• Primary Completion: May 30, 2025
• Study Completion: April 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)