Vivacit-E Post-market Follow-up Study

This is an interventional treatment trial for Osteoarthritis Read More

Inclusion Criteria:

• Patient is 18 to 60 years of age, inclusive.
• Patient is skeletally mature.
• Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following:
• Osteoarthritis
• Avascular necrosis (AVN)
• Post-traumatic arthritis
• Congenital hip dysplasia
• Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s).
• Patient is willing and able to provide written informed consent.
• Patient is willing and able to cooperate in the required post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed the IRB/EC approved informed consent.

Exclusion Criteria:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc. in the affected hip joint(s).
• Inflammatory Arthritis
• Rheumatoid Arthritis

• The patient is:

  • a prisoner mentally incompetent or unable to understand what participation in the study entails a known alcohol or drug abuser
  • anticipated to be non-compliant
  • The patient has an acute, chronic, or systemic infection(s).
  • The patient has total or partial absence of the muscular or ligamentous apparatus.
  • The patient has neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
  • The patient has osteoradionecrosis.
  • The patient has lack of bony structures proximal or distal to the operative joint, so that good implant fixation is unlikely or impossible.
  • The patient has local bone tumors/cysts in the bone to be retained that the implanting surgeon determines could inhibit implant fixation.
  • The patient is skeletally immature.
  • The patient has any concomitant disease that can jeopardize the functioning and the success of the implant.
  • The patient is known to be pregnant.
  • The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal (titanium, tivanium, tantalum, cobalt, chromium, nickel) and ceramic.