for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.

Official Title

Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery


This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.


Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures, Surgery, Osteoarthritis, Necrosis, Bone Fractures, Hip Fractures, Insignia uncemented Hip Stem


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • The subject is pregnant or breastfeeding
  • 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.
  • 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).
  • 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.


  • UCSF
    San Francisco California 94158 United States
  • Reno Orthopedic Center Foundation
    Reno Nevada 89503 United States


in progress, not accepting new patients
Start Date
Completion Date
Stryker Orthopaedics
Study Type
About 313 people participating
Last Updated