Tests a new hip implant in people needing hip replacement surgery
Tests the Insignia hip stem in adults having cementless total hip replacement for arthritis.
Plain-language title generated from the registry record
Registry title: A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
Key facts
- Where
- Subiaco, AustraliaSee the site
Where in Australia
- St. John of God Subiaco HospitalSubiaco, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stryker Australia Pty Ltd.
- Trial code
- NCT06108934
- Record updated
- 15 May 2025
- Original description
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.Read full original descriptionShow less
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
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.
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: 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.); 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; Requires revision THA or hip fusion to the affected joint; Has known sensitivity to device materials; Any involvement in an active Workers' Compensation investigation.