Trident® X3 Polyethylene Insert Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958191
First received: August 11, 2009
Last updated: November 12, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Arthroplasty, Replacement, Hip
Device: Trident® X3 Polyethylene Insert

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Mean Linear Wear Rate at 5 Years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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

  • Incidence of Revision of Component for Any Reason [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
    Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.


Secondary Outcome Measures:
  • Linear Wear Rate of the Trident X3 Polyethylene Insert [ Time Frame: 3 and 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Volumetric Wear Rate of the Trident X3 Polyethylene Insert [ Time Frame: 3,4 and 5 years ] [ Designated as safety issue: Yes ]
    Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate.

  • Radiographic Stability [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: Yes ]
    Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.

  • Harris Hip Score (HHS) Change [ Time Frame: pre-opearative, 1,3 and 5 years ] [ Designated as safety issue: No ]

    The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.

    90 - 100 = excellent

    80 - 89 = good

    70 - 79 = fair

    0 - 69 = poor


  • Change in Harris Hip Score (HHS) Pain [ Time Frame: pre-operative, 1,3, and 5 years ] [ Designated as safety issue: No ]

    The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.

    • None or ignores it = 44 points
    • Slight, occasional, no compromise in activities = 40 points
    • Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points
    • Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points
    • Marked pain, serious limitation of activites = 10 points
    • Totally disabled, crippled, pain in bed, bedridden = 0 points

  • Harris Hip Score (HHS) Range of Motion (ROM) Change [ Time Frame: pre-operative, 1,3 and 5 years ] [ Designated as safety issue: No ]

    The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.

    • 211-300 degrees = 5 points
    • 161 to 210 degrees = 4 points
    • 101 to 160 degrees = 3 points
    • 61 to 100 degrees = 2 points
    • 31 to 60 degrees = 1 points
    • 0 to 30 degrees = 0 points

  • SF-12 Health Survey Change [ Time Frame: pre-operative, 1,3 and 5 years ] [ Designated as safety issue: No ]
    Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

  • Lower Extremity Activity Scale (LEAS) Change [ Time Frame: pre-operative, 1,3 and 5 years ] [ Designated as safety issue: No ]
    Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

  • Implant Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: May 2005
Estimated Study Completion Date: December 2017
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Trident® X3 Polyethylene Insert
Participants who received the Trident® X3 Polyethylene Insert.
Device: Trident® X3 Polyethylene Insert
Trident® X3 Polyethylene Insert

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.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958191

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Bonutti Research Inc.
Effingham, Illinois, United States, 62401
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202-5111
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
United States, Michigan
J. Wesley Mesko, MD
Lansing, Michigan, United States, 48910
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68845
United States, Pennsylvania
Greater Pittsburgh Orthopaedics Assoc
Pittsburgh, Pennsylvania, United States, 15108-4305
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: James D'Antonio, MD Greater Pittsburgh Orthopaedic Association
Principal Investigator: 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
  More Information

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00958191     History of Changes
Other Study ID Numbers: 57 
Study First Received: August 11, 2009
Results First Received: April 4, 2014
Last Updated: November 12, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 26, 2016