NCT06108934Recruiting
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 313 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 22 Feb 2024
- Primary completion date
- Mar 2028
- Lead sponsor
- Stryker Australia Pty Ltd.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06108934
What you commit to
- Study type: Interventional
- Planned participants: 313
- From 22 Feb 2024 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Other illness
- 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.
Other
- Requires revision THA or hip fusion to the affected joint.
- Has known sensitivity to device materials.
- Any involvement in an active Workers' Compensation investigation
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. John of God Subiaco Hospital Coordinator of this site? Confirm its status | Subiaco | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.