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Tests treatment safety and results for Arthroplasty
Official title Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
ClinicalTrials.gov ID: NCT04848896
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
- Subject requires a cemented TKA as a primary indication that meets any of the following condition:
- Non-inflammatory degenerative joint disease, including osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis
You likely can't join if
- Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant...
- Subject has been diagnosed with post-traumatic arthritis.
- Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
- Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the...
- Subject does not understand the language used in the Informed Consent Form.
- Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).
See the full eligibility criteria
- Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
- Subject requires a cemented TKA as a primary indication that meets any of the following condition:
- Non-inflammatory 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...
- Subject plans to be available through two (2) year postoperative follow-up.
- Applicable routine radiographic assessment is possible.
- Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the 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 receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
- Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee...
- Subject does not understand the language used in the Informed Consent Form.
- Subject does not meet the indication or is contraindicated for TKA according to the 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 currently enrolled in another orthopedic clinical trial study.
- Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency...
- 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, intellectual disability, drug...
- 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 International Organization for Standardization (ISO) 14155:2020 Section 3.55.
The study team makes the final eligibility decision.
Where it's taking place
- Epping, Australia
- Beijing, China
- Shatin, Hong Kong
- Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Epping, Australia; Beijing, China; Shatin, Hong Kong; Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.