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

A Prospective, Multi-center, Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) Procedures

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).

Study Overview

• Status: Completed
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Device: CORI Robotics

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hanover, Germany, 30625
    • Orthopaedic clinic of the Medical School Hannover
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
• India
  • Maharashtra
    • Pune, Maharashtra, India, 411044
      • Lokmanya Hospital
• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B31 2AP
      • The Royal Orthopaedic Hospital NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Orthopedic Institute of the West
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Duke Health
  • Ohio
    • New Albany, Ohio, United States, 43054
      • OrthoNeuro
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

    1. Non-inflammatory degenerative joint disease, including osteoarthritis
    2. Avascular necrosis
    3. Requires correction of functional deformity
    4. 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:

    1. Degenerative joint disease, including osteoarthritis
    2. Rheumatoid arthritis
    3. Avascular necrosis
    4. Requires correction of functional deformity
    5. 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.
• Subject plans to be available through one (1) year postoperative follow-up.
• Routine radiographic assessment is possible.
• Subject able to follow instructions and deemed capable of completing all study questionnaires.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CORI Robotics; Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.	Device: CORI Robotics; Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component Alignment: Tibial Antero-Posterior (A/P) Angle	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the tibial angle denotes the angle formed on the medial side of the knee from intersecting lines parallel to the tibial base plate and a line drawn parallel to the tibial canal.	6 weeks
Component Alignment: Femoral Antero-Posterior (A/P) Angle	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the femoral flexion angle is to be obtained using standard radiographic tools. Femoral flexion angle is defined as the angle formed between a line across the base of the femoral condyles and a line that is centered along the femoral canal.	6 weeks
Component Alignment: Total Valgus Angle	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The total valgus angle is the sum of the femoral flexion angle and the tibial angle.	6 weeks
Component Alignment: Femoral Flexion Angle	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view femoral flexion angle is obtained from the intersection of a line from the center of the femoral implant to the top of the femur with a line through the femoral canal. The angle is measured on the proximal side of the intersection.	6 weeks
Component Alignment: Tibial Lateral Angle	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view tibial angle is the angle obtained from the intersection of a line drawn parallel to the bottom of the tibial base insert and a line through the center of the tibial base and the tibial canal.	6 weeks
Radiographic Assessment: Radiographic Findings	Radiographic assessment on antero-posterior (A/P) and lateral (L) views were performed to identify radiographic findings for the presence of radiolucent lines, osteolysis and implant migration. The number of participants with radiographic findings were categorized as one of the following: Yes; No; Missing	12 months
2011 Knee Society Score (KSS): Objective Score	The 2011 Knee Society Score Objective score is completed by the surgeon and assesses the condition of the knee based on factors like pain, alignment, ligament stability, and range of motion. The Objective score ranges from 0 to 100, with a higher score indicating better knee function (i.e., a better outcome).	Pre-op, 6 weeks, 6 months and 12 months
2011 Knee Society Score (KSS): Function Score	The 2011 Knee Society Score Function assesses the participant's ability to perform daily activities and is a component of the overall KSS evaluation. The Function score ranges from 0 to 100, with a higher score indicating better function (i.e., a better outcome).	Pre-op, 6 weeks, 6 months and 12 months
2011 Knee Society Score (KSS): Satisfaction Score	The 2011 Knee Society Score Satisfaction score is a five question 40-point scale completed by the participant. The Satisfaction score ranges from 0 to 40, with a higher score indicating greater satisfaction (i.e., a better outcome).	Pre-op, 6 weeks, 6 months and 12 months
Oxford Knee Score (OKS)	The Oxford Knee Score (OKS) specifically assesses the patient's perspective following knee arthroplasty surgery to indicate knee function. Total overall scores range from 0 to 48. A score of 0 is the worst possible outcome while a score of 48 indicates the best possible outcome.	Pre-op, 6 weeks, 6 months and 12 months
Forgotten Joint Score (FJS)	The forgotten Joint Score (FJS) consisted of 12 questions with responses recorded using a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores were summed and linearly transformed to a 0 to 100 scale and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome (i.e., a high score indicated a better outcome).	6 weeks, 6 months and 12 months
Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score	The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score uses a scale from 0 to 100, with 0 indicating 'the worst health you can imagine' (i.e., a worse outcome) and 100 indicating 'the best health you can imagine' (i.e., a better outcome).	Pre-op, 6 weeks, 6 months and 12 months
Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score	The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., index score) and the EQ Visual Analogue scale (EQ VAS). The descriptive system is a health-related quality of life score that comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. A score of 1 indicates perfect health-related quality of life and 0 indicates no health-related quality of life (i.e., a higher score is a better outcome). Index scores cannot be greater than 1 but could be less than 0.	Pre-op, 6 weeks, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Samantha O'Neill, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 6, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Unicompartmental Knee Arthroplasty
• Other Study ID Numbers: CORI.2019.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes