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

25 Participants Needed

Trial Summary

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 data supports the effectiveness of the Insignia Hip Stem treatment for hip replacement?

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 for similar designs. This suggests that the Insignia Hip Stem could also be effective for hip replacement. ^{1 2 3 4 5}

Is the Insignia Hip Stem generally safe for hip replacement surgery?

The safety of hip replacement surgeries, including those using different hip stems, can be affected by factors like age, obesity, and the size of the femoral head used. Common issues include infections and loosening of the implant, which can lead to further surgeries. However, specific safety data for the Insignia Hip Stem itself is not provided in the available research. ^{6 7 8 9 10}

How does the Insignia Hip Stem treatment differ from other hip replacement treatments?

The Insignia Hip Stem is unique because it is a cementless, press-fit stem designed for hip replacement, which may offer different outcomes compared to other stems like the Accolade or Modulus systems. Unlike traditional cemented stems, cementless stems aim to achieve biological fixation, potentially reducing the risk of aseptic loosening and improving long-term stability. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.

Research Team

Eric Bohm, MD MSc FRCSC

Principal Investigator

Orthopaedic Innovation Centre

Eligibility Criteria

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

Ability to give informed consent

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of symmetrical restoration for the migration of uncemented total hip arthroplasty: a randomized RSA study with 75 patients and 5-year follow-up. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Medium- and long-term performance of 11,516 uncemented primary femoral stems from the Norwegian arthroplasty register. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Outcome after total hip arthroplasty: Part II. Disease-specific follow-up and the Swedish National Total Hip Arthroplasty Register. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Better functional outcome after single-radius TKA compared with multi-radius TKA. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Exeter total hip arthroplasty with matte or polished stems. [2019]

6. Sweden pubmed.ncbi.nlm.nih.gov

Only 8% of major preventable adverse events after hip arthroplasty are filed as claims: a Swedish multi-center cohort study on 1,998 patients. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Validation of adverse events after hip arthroplasty: a Swedish multi-centre cohort study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Femoral head size is a risk factor for total hip luxation: a study of 42,987 primary hip arthroplasties from the Norwegian Arthroplasty Register. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Age and obesity are risk factors for adverse events after total hip arthroplasty. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Loosening and bone resorption in exeter hip arthroplasties. Review at a minimum of five years. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of short and mid-term outcomes of total hip arthroplasty using the Accolade™ stem. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The incidence and significance of rub marks on the stem of removed total hip replacements. [2004]

13. United States pubmed.ncbi.nlm.nih.gov

The Wisconsin noncemented femoral stem. A prospective study with 5 to 9 years of follow-up evaluation. [2019]

14. Italy pubmed.ncbi.nlm.nih.gov

Identifit: a silicone mould used to intraoperatively construct a cementless femoral stem. [2010]

15. United States pubmed.ncbi.nlm.nih.gov

Mid-term results of an uncemented femoral stem with modular neck options. [2019]