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Tritanium® Primary Acetabular Shell Study

NCT01063751 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-04-16

Study results available
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Summary

This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface.

The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.

Conditions

  • Arthroplasty, Replacement, Hip

Interventions

DEVICE

Tritanium® Primary Acetabular Shell

Tritanium® Primary Acetabular Shell in total hip replacement.

Sponsors & Collaborators

  • Stryker Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Kevin Kopko, MD · Syracuse Orthopedic Specialists, P.C.

  • John Noble, MD · Center for Orthopaedics and Spine, LLP

  • Carmen Crofoot, MD · Northern Light Eastern Maine Medical Center

  • John Diana, MD · Adventist Health St. Helena

  • Stephen Duncan, MD · University of Kentucky Research Foundation

  • Brock Lindsey, MD · West Virginia University

  • Stephen Raterman, MD · Florida Medical Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2022-05-05
Completion
2023-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063751 on ClinicalTrials.gov