Phase
Condition
Orthopedics
Treatment
CORI Robotics
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and acompatible Smith+Nephew Knee Implant System is the best treatment for the subject'sunicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subjecthas agreed to the treatment.
Subject requires a cemented UKA or TKA as a primary indication that meets eithercriterion A or B.
A. Subject requires a cemented UKA as a primary indication due to any of thefollowing conditions:
- Non-inflammatory degenerative joint disease, including osteoarthritis
- Avascular necrosis
- Requires correction of functional deformity
- Requires treatment of fractures that were unmanageable using othertechniques
- B. Subject requires a cemented TKA as a primary indication due to any of thefollowing condition:
- Degenerative joint disease, including osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis
- Requires correction of functional deformity
- Requires treatment of fractures that were unmanageable using othertechniques
Subject is of legal age to consent and considered skeletally mature (≥ 18 years ofage at the time of surgery)
Subject agrees to consent to and to follow the study visit schedule (as defined inthe 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 studyquestionnaires.
Exclusion
Exclusion Criteria:
Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for apreviously failed surgery, or need for complex implants, or any other implant than astandard 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 accordingto 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 jointdisease 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 oroutcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscularatrophy, uncontrolled diabetes, moderate to severe renal insufficiency orneuromuscular disease, or an active, local infection).
Subject in the opinion of the Investigator, has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in thestudy including mental illness, mental retardation, drug or alcohol abuse.
Subject, in the opinion of the Investigator, has a neuromuscular disorder thatprohibited control of the index joint.
Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155Section 3.55.
Study Design
Connect with a study center
Orthopaedic clinic of the Medical School Hannover
Hannover, 30625
GermanySite Not Available
Pius-Hospital Oldenburg
Oldenburg, 26121
GermanySite Not Available
Lokmanya Hospital
Pune, Maharashtra 411044
IndiaSite Not Available
The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, West Midlands B31 2AP
United KingdomSite Not Available
Orthopedic Institute of the West
Phoenix, Arizona 85054
United StatesSite Not Available
Duke Health
Morrisville, North Carolina 27560
United StatesSite Not Available
OrthoNeuro
New Albany, Ohio 43054
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.