Trident II Tritanium Acetabular Shell Outcomes Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02999009
• Other study ID #: 78
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: March 2031

Study information

• Verified date: December 2023
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 383
• Est. completion date: March 2031
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.

C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.

D. Patient is a candidate for a primary cementless total hip replacement.

E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusion Criteria:

F. Patient has a Body Mass Index (BMI) = 40.

G. Patient is diagnosed with Inflammatory Arthritis.

H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.

J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.

M. Patient has had previous open surgery to the affected joint, not including arthroscopy.

N. Patient requires implantation of a constrained liner.

O. Patient has a known sensitivity to device materials.

P. Patient is a prisoner.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Trident II Tritanium Acetabular Shell
A hemispherical acetabular shell indicated for cementless application.

Locations

Country	Name	City	State
United States	UNC Orthopaedics	Chapel Hill	North Carolina
United States	American Hip Institute	Des Plaines	Illinois
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Southeast Orthopedic Specialists	Jacksonville	Florida
United States	Center for Orthopaedics and Spine, LLC	Lake Charles	Louisiana
United States	Hospital for Special Surgery	New York	New York
United States	Northwell Health, Lenox Hill Hospital	New York	New York
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	St. Joseph Mercy Hospital Health System	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Revision for the Trident II Tritanium Acetabular Shell		5 years
Secondary	All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell	Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated	10 years
Secondary	Radiographic Stability	Numerous parameters will be reviewed by zone, including radiolucency and migration.	6 weeks, 3-6 months, 1, 2, 5, 7, 10 years