Clinical trial NCT02999009: Trident II Tritanium Acetabular Shell Outcomes Study
Official title: A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2016-12-21
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absence of Revision for the Trident II Tritanium Acetabular Shell
timeFrame: 5 years
Secondary outcomes:
measure: All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell
timeFrame: 10 years
measure: Radiographic Stability
timeFrame: 6 weeks, 3-6 months, 1, 2, 5, 7, 10 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Jacksonville
country: United States
facility: Southeast Orthopedic Specialists
state: Florida
city: Des Plaines
country: United States
facility: American Hip Institute
state: Illinois
city: Lake Charles
country: United States
facility: Center for Orthopaedics and Spine, LLC
state: Louisiana
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital Health System
state: Michigan
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Northwell Health, Lenox Hill Hospital
state: New York
city: Chapel Hill
country: United States
facility: UNC Orthopaedics
state: North Carolina
Study officials:
affiliation: Sr Director, Clinical Research - Stryker Joint Replacement
name: Manoshi Stoker
role: STUDY_DIRECTOR
References: