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RECRUITING
NCT06108934
NA

A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.

Sponsor: Stryker Australia Pty Ltd.

View on ClinicalTrials.gov

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.

Official title: A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

313

Start Date

2024-02-22

Completion Date

2028-12

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia