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

Korábbi kezelés

• 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 is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
• Subjects who have participated previously in this clinical trial and who have been withdrawn.

Más betegség

• 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.
• 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.

Egyéb

• 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.
• 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.
• Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.

• A) 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
• 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).