NL-OMON53848
Completed
Not Applicable
A Multi-Centre Study in Patients Undergoing Total Knee Replacement with Smith+Nephew Porous Total Knee Arthroplasty (TKA) System. - POROUS.TKA.SYSTEM.2021.07
Smith&Nephew, Inc0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- Smith&Nephew, Inc
- Enrollment
- 30
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject needing primary TKA due to degenerative joint disease (primary
- •diagnosis of osteoarthritis), post\-traumatic arthritis or inflammatory
- •2\. Subject agrees to consent and to follow the prospective study visit schedule
- •(as defined in the study protocol and informed consent form) by signing the
- •Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved
- •informed consent form.
- •3\. Subject is willing to attend study follow\-up visits for up to five (5\) years
- •post\-surgery.
- •4\. Subject is able to read, understand, and communicate responses to Patient
- •Reported Outcome assessments.
Exclusion Criteria
- •1\. Subject received TKA on the contralateral knee as a revision for a
- •previously failed total or unicondylar knee arthroplasty.
- •2\. Subject has a Body Mass Index (BMI) \>\= 40 at time of surgery.
- •3\. Subject has ipsilateral hip arthritis resulting in flexion contracture.
- •4\. At the time of enrolment, subject has one or more of the following
- •arthroplasties that are not fully healed and well\-functioning, as determined by
- •the investigator: Ipsilateral or contralateral primary total hip arthroplasty
- •or hip resurfacing arthroplasty; Contralateral primary total knee or
- •unicondylar
- •knee arthroplasty.
Outcomes
Primary Outcomes
Not specified
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