Insignia™ Hip Stem Outcomes Study

Korábbi kezelés

• The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
• The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

Más betegség

• The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
• The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

Egyéb

• The subject is pregnant or breastfeeding
• The subject has a known sensitivity to device materials.
• The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
• The subject is a prisoner.

• The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
• The subject is skeletally mature
• The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
• The subject is a candidate for a primary or revision cementless THA.
• The subject is willing and able to comply with postoperative scheduled clinical evaluations.