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Trident II Revision Outcomes Study

NCT ID: NCT04317586

Last Updated: 2023-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2023-01-27

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Hip Revision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trident II Tritanium Acetabular Shell for Revision

Group Type OTHER

Trident II Tritanium Acetabular Shell for Revision

Intervention Type DEVICE

A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)

Interventions

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Trident II Tritanium Acetabular Shell for Revision

A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lafayette General Orthopedic Center

Lafayette, Louisiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Beaumont Hospital Research Institute

Royal Oak, Michigan, United States

Site Status

The Orthopaedic & Fracture Clinic, P.A.

Mankato, Minnesota, United States

Site Status

Reno Orthopedic Center Foundation

Reno, Nevada, United States

Site Status

OrthoNY

Albany, New York, United States

Site Status

Syracuse Orthopedic Specialists

New York, New York, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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79

Identifier Type: -

Identifier Source: org_study_id