Status:
RECRUITING
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
Lead Sponsor:
Stryker Australia Pty Ltd.
Conditions:
Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT06108934
Start Date
February 22 2024
End Date
December 1 2028
Last Update
May 15 2025
Active Locations (1)
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1
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008