Tritanium® Primary Acetabular Shell Study

NCT ID: NCT01063751

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2023-12-30

Brief 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.

Detailed Description

The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study.

A prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer.

Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tritanium® Primary Acetabular Shell

Tritanium® Primary Acetabular Shell

Group Type: OTHER

Tritanium® Primary Acetabular Shell

Intervention Type: DEVICE

Tritanium® Primary Acetabular Shell in total hip replacement.

Interventions

Tritanium® Primary Acetabular Shell

Tritanium® Primary Acetabular Shell in total hip replacement.

Intervention Type: DEVICE

Eligibility Criteria

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 years or older at time of study device implantation.
• C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• 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 and rehabilitation.

Exclusion Criteria

• F. Patient has a Body Mass Index (BMI) ≥ 40.
• G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
• H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
• I. 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.
• J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
• K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
• L. Patient has a known sensitivity to device materials.
• M. Patient is a prisoner.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Kopko, MD

Role: PRINCIPAL_INVESTIGATOR

Syracuse Orthopedic Specialists, P.C.

John Noble, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Orthopaedics and Spine, LLP

Carmen Crofoot, MD

Role: PRINCIPAL_INVESTIGATOR

Northern Light Eastern Maine Medical Center

John Diana, MD

Role: PRINCIPAL_INVESTIGATOR

Adventist Health St. Helena

Stephen Duncan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky Research Foundation

Brock Lindsey, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Stephen Raterman, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Medical Clinic

Locations

Adventist Health St. Helena

St. Helena, California, United States

Florida Medical Clinic

Tampa, Florida, United States

University of Kentucky Research Foundation

Lexington, Kentucky, United States

Center for Orthopaedics and Spine, LLP

Lake Charles, Louisiana, United States

Northern Light Eastern Maine Medical Center

Bangor, Maine, United States

Syracuse Orthopedic Specialists, P.C.

Syracuse, New York, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

69

Identifier Type: -

Identifier Source: org_study_id