CTRI/2021/07/035056
Completed
未知
Prospective Multicenter, Study to evaluate the Safety and Effectiveness of CORI Robotics System in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) procedures
Smith and Nephew Inc0 sites7 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Smith and Nephew Inc
- Enrollment
- 7
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
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.
Outcomes
Primary Outcomes
Not specified
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