Trident® X3 Polyethylene Insert Study

NCT ID: NCT00958191

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2016-12-31

Brief Summary

The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.

Detailed Description

The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.

Conditions

Arthroplasty, Replacement, Hip

Study Design

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

Study Groups

Trident® X3 Polyethylene Insert

Participants who received the Trident® X3 Polyethylene Insert.

Group Type: OTHER

Trident® X3 Polyethylene Insert

Intervention Type: DEVICE

Trident® X3 Polyethylene Insert

Interventions

Trident® X3 Polyethylene Insert

Trident® X3 Polyethylene Insert

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The patient has signed an IRB-approved, study specific Patient Informed Consent Form.

2. The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.

3. The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.

4. The patient is a male or non-pregnant female patient ages 21 to 75.

5. The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

1. The patient has an active infection with the affected hip joint.

2. The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.

3. The patient has a BMI >45.

4. The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.

5. The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).

6. The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.

7. The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.

8. The patient is a prisoner.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James D'Antonio, MD

Role: STUDY_CHAIR

Greater Pittsburgh Orthopaedic Association

Benjamin Bierbaum, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital Deptartment of Orthopaedics

Peter Bonutti, MD

Role: PRINCIPAL_INVESTIGATOR

Bonutti Clinic

William Capello, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Michael Taunton, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Department of Orthopaedic Surgery

Robert Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation

J. Wesley Mesko, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Orthopaedic Center

James R Roberson, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Orthopaedics

John Wright, MD

Role: PRINCIPAL_INVESTIGATOR

New West Orthopaedics

Daniel Ward, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital Department of Orthopaedics

Russell Meldrum, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

J. Andrew Parr, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Steven Incavo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Greg Erens, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Orthopaedics

Robert Trousdale, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Department of Orthopaedic Surgery

Alren Hanssen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Department of Orthopaedic Surgery

Locations

Emory University

Atlanta, Georgia, United States

Bonutti Research Inc.

Effingham, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

New England Baptist Hospital

Boston, Massachusetts, United States

J. Wesley Mesko, MD

Lansing, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Good Samaritan Hospital

Kearney, Nebraska, United States

Greater Pittsburgh Orthopaedics Assoc

Pittsburgh, Pennsylvania, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

Countries

United States

Other Identifiers

57

Identifier Type: -

Identifier Source: org_study_id