Trident® X3 Polyethylene Insert Study

An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Illinois
    • Effingham, Illinois, United States, 62401
      • Bonutti Research Inc.
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5111
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
  • Michigan
    • Lansing, Michigan, United States, 48910
      • J. Wesley Mesko, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Kearney, Nebraska, United States, 68845
      • Good Samaritan Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15108-4305
      • Greater Pittsburgh Orthopaedics Assoc
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trident® X3 Polyethylene Insert; Participants who received the Trident® X3 Polyethylene Insert.	Device: Trident® X3 Polyethylene Insert; Trident® X3 Polyethylene Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear Wear Rate of the Trident X3 Polyethylene Insert	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. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.	2, 3 and 4 year films collected; 3 and 4 year wear assessed
Volumetric Wear Rate of the Trident X3 Polyethylene Insert	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. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.	2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed
Radiographic Stability	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 or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.	1,2,3,4 and 5 years
Mean Harris Hip Score (HHS) to Assess Change	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	pre-operative, 1,3 and 5 years
Mean Harris Hip Score (HHS) Pain Score to Assess Change	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	pre-operative, 1,3, and 5 years
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change	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	pre-operative, 1,3 and 5 years
Mean SF-12 Health Survey Score to Assess Change	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.	pre-operative, 1,3 and 5 years
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change	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.	pre-operative, 1,3 and 5 years
Implant Survivorship	Implant survivorship is determined using the Kaplan-Meier method.	10 years

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Peter Bonutti, MD, Bonutti Clinic; Study Chair: James D'Antonio, MD, Greater Pittsburgh Orthopaedic Association; Principal Investigator: Benjamin Bierbaum, MD, New England Baptist Hospital Deptartment of Orthopaedics; 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

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No