A Multi-Center study in Patients Undergoing Total Knee Replacement with Smith+Nephew Porous Total Knee Arthroplasty (TKA) Systems
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Osteoarthritis
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Age: Between 18 years - 90 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis OR
- Subject has undergone primary TKA with Smith+Nephew Porous knee system in past 12 months to repair degenerative joint disease, post traumatic arthritis or inflammatory arthritis and all the following conditions have been met:
- Preoperative KOOS JR and radiographs have been obtained
- 6-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events
- 12-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events
- Subject agrees to consent and to follow the prospective study visit schedule
- Subject is willing to attend study follow-up visits for up to ten (10) years post-surgery
- Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments
You may not be eligible for this study if the following are true:
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- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject has a Body Mass Index (BMI) >= 40 at time of surgery
- Subject has ipsilateral hip arthritis resulting in flexion contracture.
- 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
- Subject has a condition that may interfere with the TKA survival or outcome
- Subject has a known allergy to one or more of its components of the study device
- Any subject with hardware present in distal femur or proximal tibia
- Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days
- 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, drug or alcohol abuse
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures
- Subjects who have participated previously in this clinical trial and who have been withdrawn
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.