Trident II Tritanium Acetabular Shell Outcomes Study

Stryker

Status: Active, not recruiting

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Trident II Tritanium Acetabular Shell

Study type: Interventional

Funder types: Industry

Identifiers

NCT02999009

78

Details and patient eligibility

About

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.

Full description

This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.

Enrollment: 383 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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383 participants in 1 patient group

Trident II Tritanium Acetabular Shell

Other group

Description:

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

Treatment:

Device: Trident II Tritanium Acetabular Shell