Trident® X3 Polyethylene Insert Study

NCT00958191 | Completed Results

• 1 other identifier: 57
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 9

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.

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (2)

• Mean Linear Wear Rate at 5 Years

  Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years

  5 years

• Rate of Incidence of Revision of Component for Any Reason

  Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.

  5 year

Secondary Outcomes (9)

• Linear Wear Rate of the Trident X3 Polyethylene Insert

  2, 3 and 4 year films collected; 3 and 4 year wear assessed

• Volumetric Wear Rate of the Trident X3 Polyethylene Insert

  2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed

• Radiographic Stability

  1,2,3,4 and 5 years

• Mean Harris Hip Score (HHS) to Assess Change

  pre-operative, 1,3 and 5 years

• Mean Harris Hip Score (HHS) Pain Score to Assess Change

  pre-operative, 1,3, and 5 years

Study Arms (1)

Trident® X3 Polyethylene Insert

OTHER

Participants who received the Trident® X3 Polyethylene Insert.

Device: Trident® X3 Polyethylene Insert

Interventions

Trident® X3 Polyethylene Insert DEVICE

Trident® X3 Polyethylene Insert

Trident® X3 Polyethylene Insert

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
• The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
• 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.
• The patient is a male or non-pregnant female patient ages 21 to 75.
• The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• The patient has an active infection with the affected hip joint.
• The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
• The patient has a BMI \>45.
• The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
• The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
• The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
• The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
• The patient is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (9)

Emory University

Atlanta, Georgia, 30329, United States

Location

Bonutti Research Inc.

Effingham, Illinois, 62401, United States

Location

Indiana University

Indianapolis, Indiana, 46202-5111, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

J. Wesley Mesko, MD

Lansing, Michigan, 48910, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Good Samaritan Hospital

Kearney, Nebraska, 68845, United States

Location

Greater Pittsburgh Orthopaedics Assoc

Pittsburgh, Pennsylvania, 15108-4305, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Stryker Orthopaedics

Ellen.Axelson@stryker.com

201-831-5401

Study Officials

• James D'Antonio, MD

  Greater Pittsburgh Orthopaedic Association

  STUDY CHAIR

• Benjamin Bierbaum, MD

  New England Baptist Hospital Deptartment of Orthopaedics

  PRINCIPAL INVESTIGATOR

• Peter Bonutti, MD

  Bonutti Clinic

  PRINCIPAL INVESTIGATOR

• William Capello, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Michael Taunton, MD

  Mayo Clinic Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

• Robert Johnson, MD

  University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation

  PRINCIPAL INVESTIGATOR

• J. Wesley Mesko, MD

  Michigan Orthopaedic Center

  PRINCIPAL INVESTIGATOR

• James R Roberson, MD

  Emory Orthopaedics

  PRINCIPAL INVESTIGATOR

• John Wright, MD

  New West Orthopaedics

  PRINCIPAL INVESTIGATOR

• Daniel Ward, MD

  New England Baptist Hospital Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

• Russell Meldrum, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• J. Andrew Parr, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Steven Incavo, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

• Greg Erens, MD

  Emory Orthopaedics

  PRINCIPAL INVESTIGATOR

• Robert Trousdale, MD

  Mayo Clinic Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

• Alren Hanssen, MD

  Mayo Clinic Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: May 1, 2005
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2016
• Last Updated: February 23, 2018
• Results First Posted: July 14, 2014

Record last verified: 2018-01

Locations

US (9)