Actively Recruiting
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
Led by Stryker Australia Pty Ltd. · Updated on 2025-05-15
313
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 hip replacement surgery compared to currently available stems used for the same type of surgery. It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.
CONDITIONS
Official Title
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has signed the study-specific, Human Research Ethics Committee 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 total hip arthroplasty
- Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period
You will not qualify if you...
- Active or suspected latent infection in or about the affected hip joint at the time of study device implantation
- Any mental or neuromuscular disorder creating an unacceptable risk of prosthesis instability, fixation failure, or complications in post-operative care
- Bone stock compromised by disease, infection, or prior implantation that cannot support or fixate the prosthesis
- Immunologically suppressed or receiving steroids beyond normal physiological requirements for more than 30 days
- Requires revision total hip arthroplasty or hip fusion to the affected joint
- Known sensitivity to device materials
- Involvement in an active Workers' Compensation investigation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
Research Team
H
Holly Solomon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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