Evaluating the Insignia hip stem in total hip replacement surgery
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
This study is testing if the Insignia hip stem used in hip replacement surgery works as well as other hip stems by looking at how long it lasts and how patients feel after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 313 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stryker South Pacific Industry-sponsored |
| Locations | 1 site (Subiaco, Western Australia) |
| Trial ID | NCT06108934 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the survivorship and patient-reported outcomes following the implantation of the Insignia hip stem in patients undergoing cementless total hip replacement (THA). It compares the revision rates of the Insignia stem to currently available hip stems used in similar surgeries. The hypothesis is that the 2-year survivorship of the Insignia stem will be noninferior to the benchmark survivorship of existing stems. Participants will be monitored for their outcomes over a specified follow-up period.
Who should consider this trial
Good fit: Ideal candidates include patients with primary non-inflammatory degenerative joint disease or rheumatoid arthritis who are suitable for primary cementless total hip arthroplasty.
Not a fit: Patients with active infections, significant neuromuscular disorders, or compromised bone stock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and longevity of hip implants for patients undergoing total hip replacement.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating hip implants, suggesting this methodology is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Subiaco, Western Australia
- St John of God Subiaco Hospital — Subiaco, Western Australia, Australia (Recruiting)
Study contacts
- Principal investigator: Gavin Clark, MD — Perth Hip and Knee
- Study coordinator: Holly Solomon
- Email: holly.solomon@stryker.com
- Phone: +61405307762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.