Trident® X3 Polyethylene Insert Study
|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.|
- 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
- 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.
- Linear Wear Rate of the Trident X3 Polyethylene Insert [ Time Frame: 3 and 4 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.
- Volumetric Wear Rate of the Trident X3 Polyethylene Insert [ Time Frame: 3,4 and 5 years ]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 ]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 ]
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 ]
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 ]
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 ]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 ]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 ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Trident® X3 Polyethylene Insert
Participants who received the Trident® X3 Polyethylene Insert.
Device: Trident® X3 Polyethylene Insert
Trident® X3 Polyethylene Insert
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958191
|United States, Georgia|
|Atlanta, Georgia, United States, 30329|
|United States, Illinois|
|Bonutti Research Inc.|
|Effingham, Illinois, United States, 62401|
|United States, Indiana|
|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|
|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|
|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|