RecruitingNot ApplicableNCT06108934

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)


Sponsor

Stryker Australia Pty Ltd.

Enrollment

313 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients who receive the Insignia Hip Stem, a new cementless hip implant, during total hip replacement surgery. The goal is to track how well the implant lasts over time and measure patient-reported outcomes like pain and mobility. **You may be eligible if...** - You have joint disease that requires a primary (first-time) total hip replacement, such as osteoarthritis, avascular necrosis, or rheumatoid arthritis - You are a candidate for a cementless hip replacement - You have signed informed consent and are willing to attend follow-up visits **You may NOT be eligible if...** - You have an active or suspected infection in or near the hip - You have a mental or neuromuscular disorder that would make the hip implant unstable - You have poor bone quality that cannot support the implant - You are on long-term high-dose steroids that suppress your immune system - You are involved in an active Workers' Compensation case - You are known to be sensitive to the implant materials Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHip 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.


Locations(1)

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

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NCT06108934