Clinical trial NCT04786119: Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Keywords: Unicompartmental Knee Arthroplasty
Total Knee Arthroplasty
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-08
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Post-Operative Leg Alignment
timeFrame: 6 weeks
measure: Percentage of Knees Achieving Post-Operative Leg Alignment
timeFrame: 6 weeks
Secondary outcomes:
measure: Component Alignment - UKA
timeFrame: 6 weeks
measure: Component Alignment - TKA
timeFrame: 6 weeks
measure: Radiographic Assessment - UKA
timeFrame: 12 months
measure: Radiographic Assessment - TKA
timeFrame: 12 months
measure: 2011 Knee Society Score (KSS) - UKA
timeFrame: Pre-op, 6 week, 6 month and 12 months
measure: 2011 Knee Society Score (KSS) - TKA
timeFrame: Pre-op, 6 week, 6 month and 12 months
measure: Oxford Knee Score (OKS) - UKA
timeFrame: Pre-op, 6 week, 6 month and 12 months
measure: Oxford Knee Score (OKS) - TKA
timeFrame: Pre-op, 6 week, 6 month and 12 months
measure: Forgotten Joint Score (FJS) - UKA
timeFrame: 6 week, 6 month and 12 months
measure: Forgotten Joint Score (FJS) - TKA
timeFrame: 6 week, 6 month and 12 months
measure: Five-level EuroQol Five-dimensional (EQ-5D-5L) VAS & Index Scores - UKA
timeFrame: Pre-op, 6 week, 6 month and 12 months
measure: Five-level EuroQol Five-dimensional (EQ-5D-5L) VAS & Index Scores - TKA
timeFrame: Pre-op, 6 week, 6 month and 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Orthopedic Institute of the West
state: Arizona
city: Morrisville
country: United States
facility: Duke Health
state: North Carolina
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Hannover
country: Germany
facility: Orthopaedic clinic of the Medical School Hannover
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Pune
country: India
facility: Lokmanya Hospital
state: Maharashtra
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: Smith & Nephew, Inc.
name: Julie Lankiewicz
role: STUDY_CHAIR
References: