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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02999009
Other study ID # 78
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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