A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
Condition(s) studied
Investigational drug(s) / intervention(s)
Hip stem prosthesis: The Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.
Study 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 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.
Eligibility
Primary outcome measure(s)
- Implant survivorship — 2 years post-operatively
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| St John of God Subiaco Hospital | Subiaco | Western Australia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06108934 on ClinicalTrials.gov ↗ ← All trials in Australia