A prospective, pre-market, multi-center evaluation of the clinical outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)

Stryker Australia Pty Ltd0 sites313 target enrollmentApril 18, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 18, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
•Primary non\-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
•The patient is a candidate for a primary cementless THA.
•Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow\-up period.

•Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
•Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post\-operative care.
•Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
•Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \>30 days.)
•Requires revision THA or hip fusion to the affected joint.
•Has known sensitivity to device materials.
•Any involvement in an active Workers’ Compensation investigation