Trident II Tritanium for Hip Replacement

Not currently recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Trident II Tritanium Acetabular Shell compared to similar hip replacement parts. Researchers aim to determine how often patients require additional surgery five years after receiving this part. Suitable candidates have joint disease causing hip pain and need their first hip replacement surgery.

As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance future hip replacement options.

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 prior data suggests that the Trident II Tritanium Acetabular Shell is safe for hip replacement?

Research has shown that the Trident II Tritanium Acetabular Shell is generally well-tolerated in hip replacement surgeries. The FDA has approved this device, indicating it meets safety standards for patient use. Some studies have reported rare cases of connection failure between the screw and shell, but most patients do not experience serious issues. The shell features a thin wall and options for larger heads to enhance movement and reduce wear. While occasional side effects occur, the device's safety is supported by its approval and use in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trident II Tritanium Acetabular Shell for hip replacement because it offers a novel design that enhances stability and integration with the bone. Unlike traditional metal or ceramic implants, the Tritanium shell is constructed using a 3D-printed material that mimics the structure of natural bone, potentially allowing for better bone growth and fixation. This cutting-edge approach may reduce the risk of implant loosening over time, which is a common issue with existing hip replacement options. By improving long-term outcomes, this treatment could significantly enhance the quality of life for patients undergoing hip replacement surgery.

What is the effectiveness track record for the Trident II Tritanium Acetabular Shell in hip replacement?

Research has shown that the Trident II Tritanium Acetabular Shell, which participants in this trial will receive, performs well in hip replacements. Studies have found it effective, with a low likelihood of requiring another surgery within five years. Designed for use without cement, this shell can promote natural bone growth and stability. Its design also allows for a greater range of motion, potentially improving movement after surgery. Overall, evidence supports its use as a reliable option for hip replacement patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Kevin Barga

Principal Investigator

Director, Clinical Research - Stryker Joint Replacement

Are You a Good Fit for This Trial?

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.

Patient is a prisoner

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application.

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02999009

Trident II Tritanium Acetabular Shell Outcomes Study 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04317586

NCT04317586 | Trident II Revision Outcomes Study The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10581835/

Nexus Evaluation Primary Trident II UNcemented shEll ... The results of this study will provide functional, radiological, and survival data to either support the ongoing use of the HA acetabulum or highlight potential ...

4. trial.medpath.com trial.medpath.com/clinical-trial/62d7b0e8d35af5da/nct02999009-prospective-post-market-trident-ii-acetabular-shell

Trident II Tritanium Acetabular Shell Outcomes Study - MedPath 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 ...

5. stryker.com stryker.com/us/en/joint-replacement/products/trident-ii.html

Trident II Acetabular System Trident II features a slim shell wall. This allows for large femoral head size options and optimal poly thickness to potentially aid in greater range of motion, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K171768.pdf

Howmedica Osteonics Corp. aka Stryker Orthopaedics Ms ... The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular. Inserts, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9420431/

Failure of Screw/Shell Interface in the Trident II Acetabular ... We report a case series of 2 patients with screw/shell interface failure in the Stryker Trident II Acetabular System.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT04317586/Prot_SAP_000.pdf

Trident II Acetabular Shell Revision Study The shells feature a coarse surface that provides initial fixation for cementless hip arthroplasty. The outer surface is coated with Commercially Pure (CP) ...