A Multi-Centre Study in Patients Undergoing Total Knee Replacement with Smith+Nephew Porous Total Knee Arthroplasty (TKA) System.
- Conditions
- Arthritisjoint inflammation10005944
- Registration Number
- NL-OMON53848
- Lead Sponsor
- Smith&Nephew, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subject needing primary TKA due to degenerative joint disease (primary
diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory
arthritis.
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.
5. Subject is 18-80 years old (inclusive).
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.
5. Subject has a condition that may interfere with the TKA survival or outcome
(e.g. Paget*s or Charcot*s disease, vascular insufficiency, lupus, muscular
atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or
neuromuscular disease).
6. Subject has a known allergy to one or more of its components of the study
device.
7. Any subject with hardware present in distal femur or proximal tibia.
8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155
Section 3.55.
9. Subject is entered in another drug, biologic, or device study or has been
treated with an investigational product in the past 30 days.
10. 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.
11. Subject is known to be at risk for lost to follow-up, or failure to return
for scheduled visits.
12. Women who are pregnant, nursing, or of child-bearing potential who are not
utilizing highly effective birth control measures at the time of screening or
the time of surgery or do not engage in a sexual lifestyle that makes pregnancy
impossible (e.g. homosexual or are without a sexual partner).
13. Subjects who have participated previously in this clinical trial and who
have been withdrawn.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for the study is implant survivorship 2 years<br /><br>post-surgery. Implant survivorship is defined as the cumulative proportion of<br /><br>knee-implanted components without a revision. </p><br>
- Secondary Outcome Measures
Name Time Method