Skip to main content
OpenTrials
Completed

NCT Number: NCT00958191

Trident® X3 Polyethylene Insert Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthroplasty, Replacement, Hip

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Trident® X3 Polyethylene Insert

Device

Trident® X3 Polyethylene Insert

Primary outcomes

  1. Mean Linear Wear Rate at 5 Years

    Time frame: 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

  2. Rate of Incidence of Revision of Component for Any Reason

    Time frame: 5 year

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

Secondary outcomes

  1. Linear Wear Rate of the Trident X3 Polyethylene Insert

    Time frame: 2, 3 and 4 year films collected; 3 and 4 year wear assessed

    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. Volumetric Wear Rate of the Trident X3 Polyethylene Insert

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

    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.

  3. Radiographic Stability

    Time frame: 1,2,3,4 and 5 years

    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.

  4. Mean Harris Hip Score (HHS) to Assess Change

    Time frame: pre-operative, 1,3 and 5 years

    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

  5. Mean Harris Hip Score (HHS) Pain Score to Assess Change

    Time frame: pre-operative, 1,3, and 5 years

    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

  6. Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change

    Time frame: pre-operative, 1,3 and 5 years

    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

  7. Mean SF-12 Health Survey Score to Assess Change

    Time frame: pre-operative, 1,3 and 5 years

    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.

  8. Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change

    Time frame: pre-operative, 1,3 and 5 years

    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.

  9. Implant Survivorship

    Time frame: 10 years

    Implant survivorship is determined using the Kaplan-Meier method.

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2016
First posted
Aug 13, 2009
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.