A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous K… (NCT05197036) | Clinical Trial Compass
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A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis
United States299 participantsStarted 2021-12-21
Plain-language summary
A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post-surgery.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
✓. 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.
✓. Subject is willing to attend study follow-up visits for up to five (5) years post-surgery.
✓. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments.
✓. Subject is 18-80 years old (inclusive).
Exclusion criteria
✕. 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.
What they're measuring
1
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
✕. 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 (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
✕. 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.
✕. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.