Trident II Tritanium for Hip Replacement

Recruiting at 8 trial locations

Overseen By Hannah Pacheco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: BMI ≥ 40, Inflammatory arthritis, Infection, Neuromuscular deficiency, Systemic disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate recovery

383 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking steroids in excess of normal levels, you may not be eligible to participate.

What data supports the effectiveness of the Trident II Tritanium Acetabular Shell treatment for hip replacement?

Research shows that the Tritanium acetabular cup, which is similar to the Trident II Tritanium Acetabular Shell, has a structure that mimics natural bone, promoting strong biological fixation. This suggests it may be effective in hip replacements by providing a stable and durable fit. ^{1 2 3 4 5}

Is the Trident II Tritanium Acetabular Shell safe for hip replacement?

There are some safety concerns with the Trident II Acetabular System, including issues with the seating of ceramic liners and potential screw/shell interface failures. These problems may lead to complications, but they can often be managed with careful monitoring and adjustments during surgery. ^{5 6 7 8 9}

What makes the Trident II Tritanium Acetabular Shell unique for hip replacement?

The Trident II Tritanium Acetabular Shell is unique because it uses a highly porous titanium structure that mimics natural bone, promoting stronger biological fixation and potentially reducing the risk of implant failure. This design aims to improve stability and longevity compared to conventional hip replacement options. ^{1 2 3 10 11}

Research Team

Manoshi Stoker

Principal Investigator

Sr Director, Clinical Research - Stryker Joint Replacement

Eligibility Criteria

This trial is for men and women aged 18-80 who need a primary hip replacement due to non-inflammatory joint disease. They must be able to follow the study's procedures after surgery. People with neuromuscular issues, previous hip surgeries (except arthroscopy), sensitivity to device materials, inflammatory arthritis, infections in the hip area, high steroid use, severe obesity (BMI ≥ 40), or certain systemic diseases are not eligible.

Inclusion Criteria

Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form

I am willing and able to follow up with all required post-surgery check-ups and scans.

I have been diagnosed with a type of arthritis that is not caused by inflammation.

Exclusion Criteria

I might have an infection in or near my hip where a device will be implanted.

I have had open surgery on the joint in question, but not arthroscopy.

I need surgery to fix or replace my previous hip implant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Trident II Tritanium Acetabular Shell as part of their hip replacement surgery

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with specific focus on radiographic stability and revision rates

10 years

Visits at 6 weeks, 3-6 months, 1, 2, 5, 7, and 10 years

Treatment Details

Interventions

• Trident II Tritanium Acetabular Shell

Trial Overview The Trident II Tritanium Acetabular Shell is being tested in patients undergoing cementless total hip replacements. The study aims to assess its performance by comparing the rate of revision surgeries within five years against similar devices already approved by the FDA.

Participant Groups

Group I: Trident II Tritanium Acetabular Shell Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

Findings from Research

In a review of 117 hips from 113 patients who received the Trident acetabulum in total hip replacements, 16.4% showed incomplete seating of the metal-backed ceramic liner, indicating a potential issue with the implant's design or surgical technique.

The study suggests that the Trident shell may deform during implantation, which could hinder proper seating of the liner, highlighting the need for surgeons to be aware of this complication when using this prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete seating of the liner with the Trident acetabular system: a cause for concern? Langdown, AJ., Pickard, RJ., Hobbs, CM., et al.[2016]

In a review of 68 patients who underwent total hip arthroplasties using the Trident acetabular system, 8% of the metal-backed ceramic liners were found to be incompletely seated, with a higher risk of 10% in primary surgeries compared to 0% in revision surgeries.

The study suggests that shell deformation may contribute to the malseating issue, and to mitigate this risk, the authors have adjusted their surgical technique by underreaming by 0.8 mm instead of 1.8 mm, especially in cases of sclerotic bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seating of ceramic liners in the uncemented trident acetabular shell: is there really a problem? Howcroft, DW., Qureshi, A., Graham, NM.[2021]

This case series reports two instances of screw penetration through the Stryker Trident II acetabular shell, highlighting a potential design flaw in the implant system during total hip arthroplasty procedures.

Both cases were managed conservatively with weight-bearing as tolerated and radiographic monitoring, suggesting that while the failures occurred, they did not require more invasive interventions, but they do emphasize the need for careful intraoperative assessment of screw placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of Screw/Shell Interface in the Trident II Acetabular System in Total Hip Arthroplasty. Ulrich, PA., Zondervan, RL., Cochran, JM.[2022]

References

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

Early results of a new highly porous modular acetabular cup in revision arthroplasty. [2022]

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

Long-term results of tripolar constrained total hip arthroplasty in revision hip arthroplasty: a minimum follow-up of ten years. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

Comparison of a highly porous titanium cup (Tritanium) and a conventional hydroxyapatite-coated porous titanium cup: A retrospective analysis of clinical and radiological outcomes in hip arthroplasty among Japanese patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Incomplete seating of the liner with the Trident acetabular system: a cause for concern? [2016]

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

Seating of ceramic liners in the uncemented trident acetabular shell: is there really a problem? [2021]

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

Failure of Screw/Shell Interface in the Trident II Acetabular System in Total Hip Arthroplasty. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Blood metal ions after hybrid metal-on-polyethylene Exeter-Trident total hip replacement. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Dual Modular Titanium Alloy Femoral Stem Failure Mechanisms and Suggested Clinical Approaches. [2021]

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

Do Modular Dual Mobility Cups Offer a Reliable Benefit? Minimum 5-Year Follow-Up of 102 Cups. [2022]

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

Excellent results of primary THA using a highly porous titanium cup. [2022]