Insignia Hip Stem for Hip Replacement

Overseen By Shalini Hari Kumar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Radiostereometric Analysis Network

Disqualifiers: Infection, Major surgery risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the Insignia hip stem used in hip replacement surgeries. Researchers will assess its stability over time using two imaging tests: radiostereometric analysis (RSA) and computed tomography (CT). They will also evaluate patients' comfort and mobility after surgery. The trial seeks individuals with painful hip arthritis (joint disease) who require a hip replacement. Participants should be able to follow up and perform regular self-checks. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future hip replacement outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Insignia hip stem is safe for hip replacement?

Research has shown that the Insignia Hip Stem has undergone safety testing, particularly in MRI (Magnetic Resonance Imaging) settings. Studies have assessed its fit and function in hip replacements, though specific safety details for this device are not fully covered in the available research. Since the Insignia Hip Stem is part of a study beyond its early stages, previous research has already demonstrated some level of safety. Additionally, the device is included in a long-term study conducted after its market release, ensuring ongoing monitoring of its safety and effectiveness. This information can reassure patients considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Insignia Hip Stem is unique because it offers a new approach to total hip replacement by using advanced imaging techniques to enhance surgical precision. Unlike traditional hip replacement options, which typically rely on standard radiostereometric analysis (RSA), the Insignia Hip Stem uses computed tomography (CT)-based RSA. This method provides a more detailed and accurate assessment of implant positioning and stability. Researchers are excited about this treatment because it has the potential to improve long-term outcomes for patients by ensuring better alignment and integration of the hip implant, potentially reducing the risk of complications and the need for future surgeries.

What evidence suggests that the Insignia hip stem is effective for hip replacement?

Research has shown that the Insignia hip stem, which participants in this trial will receive, effectively supports hip replacements. Patients have reported significant improvement at the 6-week mark and during their final check-ups. The Insignia hip stem employs advanced 3D modeling for a more comfortable fit with the patient's bone. Studies indicate that modern uncemented femoral stems, such as Insignia, have long-lasting durability, with survival rates of 96% to 100% over ten years. This suggests that the Insignia hip stem is a reliable option for long-term treatment of joint problems. ^{1 3 6 7 8}

Who Is on the Research Team?

Eric Bohm, MD MSc FRCSC

Principal Investigator

Orthopaedic Innovation Centre

Are You a Good Fit for This Trial?

This trial is for patients with degenerative joint disease who need a primary total hip replacement. It's designed to track how the Insignia hip stem, an implant used in such surgeries, moves over time.

Inclusion Criteria

I am over 21 and need a hip replacement due to severe arthritis.

Ability to give informed consent

Patients willing and able to comply with follow-up requirements and self-evaluations

Exclusion Criteria

I have or had an infection.

Medical condition with less than 2 years life expectancy

My skin is healthy where I will be cut for surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Assessment

Participants undergo primary total hip arthroplasty using the Insignia hip stem and initial RSA and CT-RSA imaging

1 week

Post-operative Monitoring

Participants are monitored for femoral stem migration and clinical outcomes using RSA and CT-RSA, as well as patient questionnaires

24 months

Regular visits at 6-month, 1-year, and 2-year intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Insignia

Trial Overview The study tests the migration pattern of the Insignia hip stem post-surgery using two imaging techniques: radiostereometric analysis (RSA) and computed tomography (CT). It also compares these methods and evaluates patient outcomes through questionnaires.

How Is the Trial Designed?

Group I: Insignia Experimental Treatment 1 Intervention

Total hip replacement CT-RSA vs gold standard RSA

Who Is Running the Clinical Trial?

Canadian Radiostereometric Analysis Network

Lead Sponsor

Trials

9

Recruited

420+

Orthopaedic Innovation Centre

Collaborator

Trials

7

Recruited

670+

Published Research Related to This Trial

In a study of 1809 Medicare beneficiaries who underwent total hip arthroplasty (THA) from 2002 to 2007, the overall rate of adverse events was found to be 5.8%, with increased age and obesity identified as significant risk factors.

The annual rate of adverse events decreased significantly from 9.1% in 2002 to 3.0% in 2007, indicating improvements in perioperative care, although the reasons for this decline remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age and obesity are risk factors for adverse events after total hip arthroplasty. Huddleston, JI., Wang, Y., Uquillas, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05144191

NCT05144191 | Insignia™ Hip Stem Outcomes Study The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540325003286

Early Outcomes Following Total Hip Arthroplasty With a ... Patients experienced significant improvements in their patient-reported outcome measures at both the 6-week mark and at the final postoperative follow-up visit ...

3. stryker.com stryker.com/us/en/joint-replacement/products/Insignia.html

Insignia The Insignia hip stem leverages more than 1,300 CT scans, utilizing a 3D modeling and analytics system, Stryker Orthopaedic Modeling and Analytics (SOMA) bone ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05144191

Insignia™ Hip Stem Outcomes Study - UCSF Clinical Trials The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market ...

5. withpower.com withpower.com/trial/insignia-hip-stem-for-hip-replacement-72456

Insignia Hip Stem for Hip Replacement · Info for Participants The research shows that modern uncemented femoral stems, like the Insignia Hip Stem, generally perform well, with survival rates of 96% to 100% at ten years ...

6. stryker.com stryker.com/content/dam/stryker/about/our-locations/apac/ifus/2025/Insignia-Hip-Stem-IFU-QIN-4441-REV-AUS1.0.pdf

Howmedica Osteonics INSIGNIATM HIP STEM Magnetic Resonance Imaging (MRI) Safety Information. The Insignia Hip Stem has been evaluated for safety and compatibility in the MR environment. Non ...

7. renoorthofoundation.org renoorthofoundation.org/about-7

Joint Research Studies This is a 10 year-long, post-market study assessing the Insignia™ Hip Stem for total hip replacements. The Insignia™ Hip Stem features a short stem design ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05313321

Survival of the Insignia Stem in Total Hip Arthroplasty The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines ...