JOURNEY II XR Safety and Effectiveness PMCF

Korábbi kezelés

• have any of the following conditions in the index joint:
  • Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
  • Significant varus or valgus deformities (\>15º)
  • Incomplete or insufficient tissue surrounding the knee
  • Collateral ligament insufficiency
  • Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
  • History of prior TKA
• have any of the following conditions in the contralateral joint:
  • a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
  • a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator
• have any of the following conditions of the hip:
  • a previous contralateral or ipsilateral revision hip arthroplasty
  • ipsilateral hip arthritis resulting in flexion contracture
  • previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator
• be enrolled in another drug, biologic, or device study within 30 days of screening
• during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).

Más betegség

• have a diagnosis of an immunosuppressive disorder
• have an active infection, treated or untreated, systemic or at the site of the planned surgery
• have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
• have a known allergy to study device or one or more of its components
• have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
• be known to be at risk for lost to follow-up or failure to return for scheduled visits

Egyéb

• have a BMI \> 40
• be facing current or impending incarceration
• be pregnant or have plans to become pregnant during the course of the study

• require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
• have all cruciate and collateral ligaments intact in the index joint
• adult patients that in the judgement of the Investigator are skeletally mature
• be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
• consent to participate in the study by signing the IRB/EC approved informed consent form