Trident II Revision Outcomes Study

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication

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 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.

Study Overview

• Status: Terminated
• Conditions: Arthroplasty, Hip Revision
• Intervention / Treatment: Device: Trident II Tritanium Acetabular Shell for Revision

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeff Broady; Phone Number: 201-831-5000; Email: jeff.broady@stryker.com
• Study Contact Backup: Name: Rushal Parikh; Phone Number: 201-831-5000; Email: rushal.parikh@stryker.com

Study Locations

• United States
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Lafayette General Orthopedic Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital Research Institute
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • The Orthopaedic & Fracture Clinic, P.A.
  • Nevada
    • Reno, Nevada, United States, 89503
      • Reno Orthopedic Center Foundation
  • New York
    • Albany, New York, United States, 12205
      • OrthoNY
    • New York, New York, United States, 13214
      • Syracuse Orthopedic Specialists
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.

B. Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation.

C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.

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

Exclusion Criteria:

E. Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. 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 mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.

K. 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.

L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trident II Tritanium Acetabular Shell for Revision	Device: Trident II Tritanium Acetabular Shell for Revision; A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cases Free From Trident II Acetabular Shell Revision	To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.	6 Weeks, 3-6 Months, 1 Year and 2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Stability	Radiographic stability is a composite endpoint evaluating radiolucency and migration. Radiographic stability is defined as cases (hips implanted) which do not present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones.	6 Weeks and 3-6 Months

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 79

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes