Osteoarthritis
Conditions
Interventions
Gap measurment:Tensioner test after the TKA by experts and trainees
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject's treating clinician has decided that 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. 2. Subject is of legal age to consent and considered skeletally mature (= 18 years of age at the time of surgery) 3. 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 Institutional Review Board (IRB) approved informed consent form. 4. 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: a. Non-inflammatory degenerative joint disease, including osteoarthritis b. Avascular necrosis B. Subject requires a cemented TKA as a primary indication due to any of the following condition: a. Degenerative joint disease, including osteoarthritis b. Rheumatoid arthritis c. Avascular necrosis
Exclusion criteria
Exclusion criteria: 1. Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for a previously failed surgery 2. Subject has been diagnosed with post-traumatic arthritis 3. Subject does not understand the language used in the Informed Consent Form. 4. 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). 5. Subject has active infection or sepsis (treated or untreated). 6. Subject is pregnant or breast feeding at the time of surgery. 7. 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. 8. Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155:2011 Section 3.44.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0 and 90 degree flextion gap pre bone cut; | — |
Countries
China
Contacts
Public ContactMichael TY Ong
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Outcome results
None listed