G7 Freedom Constrained Vivacit-E Liners

Korábbi kezelés

• In the opinion of the investigator, patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
• The patient is in the vulnerable population group, such as
  • a prisoner
  • a known alcohol or drug abuser
  • mentally incompetent or unable to understand what participation in this study entails

Más betegség

• Patient is septic, has an active infection or has osteomyelitis at the affected joint
• Patient has metabolic disorder(s) which may impair bone formation
• Patient has distant foci of infections which may spread to the implant site
• Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery.

Egyéb

• Patient has significant osteoporosis as defined by treating surgeon
• Patient has osteomalacia
• Patient has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
• Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
• Patient is undergoing simultaneous bilateral THA
• Patient is known to be pregnant

• Patient is 18 to 80 years of age, inclusive
• Patient is skeletally mature
• Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
  • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • High risk for dislocation
  • Undergoing revision hip arthroplasty
  • Correction of functional deformity
  • In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
• Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent