MedDataX Logo

Trident® Tritanium™ Acetabular Shell Revision Study

NCT ID: NCT00535626

Last Updated: 2017-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.

Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.

Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.

It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.

The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthroplasty, Replacement, Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trident® Tritanium™ Acetabular Shell

Trident® Tritanium™ Acetabular Shell used in revision total hip replacement

Group Type OTHER

Trident® Tritanium™ Acetabular Shell

Intervention Type DEVICE

Trident® Tritanium™ Acetabular Shell

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trident® Tritanium™ Acetabular Shell

Trident® Tritanium™ Acetabular Shell

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Males and non-pregnant females, 21-85 years of age at the time of surgery.
2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
3. Patient has signed an IRB approved study consent form.
4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.

Exclusion Criteria

1. Patient is morbidly obese, BMI \> 40.
2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (\> 30 days).
4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
5. Patient has an active or suspected latent infection on or about the hip joint.
6. Patient is a prisoner.
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stryker Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arthur Malkani, MD

Role: STUDY_CHAIR

University of Louisville

Michael Masini, MD

Role: PRINCIPAL_INVESTIGATOR

St Joseph Mercy Hospital

Daniel Ward, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital

Benjamin Bierbaum, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital

Kirby Hitt, MD

Role: PRINCIPAL_INVESTIGATOR

Scott & White Memorial Hospital

Kenneth Greene, MD

Role: PRINCIPAL_INVESTIGATOR

Crystal Clinic

Jim Kudrna, MD

Role: PRINCIPAL_INVESTIGATOR

Illinois Bone & Joint Institute

Ivan Tomek, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Stephen Kantor, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Steven Barnett, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Specialty Institute

Carlos Higuera, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Joseph Zuckerman, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Hospital for Joint Diseases

Fredrick Jaffe, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Hospital for Joint Diseases

Stephen Incavo, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Timothy Lovell, MD

Role: PRINCIPAL_INVESTIGATOR

Rockwood Clinic

Sean Scully, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Medical Center

Amar Ranawat, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Geoffrey Westrich, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

R D Heekin, MD

Role: PRINCIPAL_INVESTIGATOR

Heekin Institute for Orthopedic Research, Inc.

Bryce Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Scott & White Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orthopedic Specialty Institute

Orange, California, United States

Site Status

Heekin Institute for Orthopedic Research, Inc.

Jacksonville, Florida, United States

Site Status

Cedars Medical Center

Miami, Florida, United States

Site Status

Illinois Bone & Joint Institute

Glenview, Illinois, United States

Site Status

University of Louisville, 201 Abraham Flexner Way, Suite 100

Louisville, Kentucky, United States

Site Status

New England Baptist Hospital

Boston, Massachusetts, United States

Site Status

St Joseph Mercy Hospital

Ypsilanti, Michigan, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

NYU Hospital for Joint Diseases

New York, New York, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Crystal Clinic

Akron, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Rockwood Clinic

Spokane, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

61

Identifier Type: -

Identifier Source: org_study_id