Large Head X3 Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02543437|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2015
Results First Posted : April 6, 2016
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Joint Disease||Device: Trident Acetabular X3 Insert||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Large Diameter Head to Prevent Dislocation, and of 3 rd Generation Highly Crosslinked Polyethylene to Reduce Wear in Computer Assisted Total Hip Arthroplasty.|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||July 2019|
Trident Acetabular X3 Insert
28mm, 32mm and 36mm liner
Device: Trident Acetabular X3 Insert
- Range of Motion(ROM) (Degree) [ Time Frame: Intraoperative ]Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
- Lift Off Distance in Dislocation Maneuver(mm) [ Time Frame: Intraoperative ]Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
- Wear Rate(%) [ Time Frame: 1 year, 2 years, 3 years and 5 years after surgery ]Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543437
|Nagoya Kyoritsu Hospital|
|Nagoya City, Aichi, Japan, 454-0933|
|Yokohama City University Hospital|
|Yokohama, Kanagawa, Japan, 236-0004|
|Suita City, Osaka, Japan, 564-0001|
|Osaka City General Hospital.|
|Osaka, Japan, 534-0021|