Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures

NCT04786119 | Completed Results FDA Device

• 1 other identifier: CORI.2019.07
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 8

Brief Summary

Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications. Objectives: The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned. Research participants / locations: Research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India).

Conditions

Arthroplasty; Replacement; Knee

Keywords

Unicompartmental Knee Arthroplasty; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Post-Operative Leg Alignment

  The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

  6 weeks

• Percentage of Knees Achieving Post-Operative Leg Alignment

  The percentage of knees achieving post-operative leg alignment taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Percentage of knees achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

  6 weeks

Secondary Outcomes (13)

• Component Alignment: Femoral Antero-Posterior (A/P) Angle

  6 weeks

• Component Alignment: Tibial Antero-Posterior (A/P) Angle

  6 weeks

• Component Alignment: Total Valgus Angle

  6 weeks

• Component Alignment: Femoral Flexion Angle

  6 weeks

• Component Alignment: Tibial Lateral Angle

  6 weeks

Study Arms (1)

CORI Robotics

EXPERIMENTAL

Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.

Device: CORI Robotics

Interventions

CORI Robotics DEVICE

Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.

CORI Robotics

Eligibility Criteria

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

You may qualify if:

• The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject's unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment.
• Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B.
• A. Subject requires a cemented UKA as a primary indication due to any of the following conditions:
• Non-inflammatory degenerative joint disease, including osteoarthritis
• Avascular necrosis
• Requires correction of functional deformity
• Requires treatment of fractures that were unmanageable using other techniques
• B. Subject requires a cemented TKA as a primary indication due to any of the following condition:
• Degenerative joint disease, including osteoarthritis
• Rheumatoid arthritis
• Avascular necrosis
• Requires correction of functional deformity
• Requires treatment of fractures that were unmanageable using other techniques
• Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
• Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.

You may not qualify if:

• Subject receives a CORI Robotics UKA or 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 UKA or TKA (e.g. stems, augments, or custom made devices).
• Subject has been diagnosed with post-traumatic arthritis
• Subject receives bilateral UKA or TKA
• Subject does not understand the language used in the Informed Consent Form.
• Subject does not meet the indication or is contraindicated for UKA or TKA according to specific Smith+Nephew knee system's Instructions For Use (IFU).
• Subject has active infection or sepsis (treated or untreated).
• Subject is morbidly obese with a body mass index (BMI) greater than 40.
• Subject is pregnant or breast feeding at the time of surgery.
• Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
• Subject has a condition(s) that may interfere with the TKA or UKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
• Subject in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
• Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
• Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Orthopedic Institute of the West

Phoenix, Arizona, 85054, United States

Location

Duke Health

Morrisville, North Carolina, 27560, United States

Location

OrthoNeuro

New Albany, Ohio, 43054, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Orthopaedic clinic of the Medical School Hannover

Hanover, 30625, Germany

Location

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Lokmanya Hospital

Pune, Maharashtra, 411044, India

Location

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, West Midlands, B31 2AP, United Kingdom

Location

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Study Officials

• Samantha O'Neill

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: March 3, 2021
• First Posted: March 8, 2021
• Study Start: February 17, 2021
• Primary Completion: October 27, 2023
• Study Completion: September 10, 2024
• Last Updated: October 31, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); IN (1); DE (2); US (4)