MedTrace Logo

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

NCT06108934 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2025-05-15

No results posted yet for this 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.

Conditions

  • Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))

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.

Sponsors & Collaborators

  • Stryker Australia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Gavin Clark, MD · Perth Hip and Knee

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2028-03-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06108934 on ClinicalTrials.gov