Trilogy AB Acetabular Hip System Post Approval 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: NCT00715026|
Recruitment Status : Terminated (Sponsor business decision unrelated to clinical performance.)
First Posted : July 15, 2008
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Avascular Necrosis Congenital Hip Dysplasia Traumatic Arthritis||Device: Trilogy AB Acetabular Hip Implant System||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Trilogy AB Acetabular Hip Implant System
Post Approval Study of Device.
Device: Trilogy AB Acetabular Hip Implant System
Total hip replacement with ceramic on ceramic treatment surfaces.
- Harris Hip Score [ Time Frame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years ]The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.
- Continued Assessment of Implant Survivorship and Incidences of Adverse Events. [ Time Frame: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years ]A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.
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): NCT00715026
|United States, Florida|
|Shrock Orthopedic Research|
|Fort Lauderdale, Florida, United States, 33136|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Kevin Schrock, MD||Schrock Orthopedic Research|
|Principal Investigator:||Gwo-Chin Lee, MD||University of Pennsylvania/Penn Presbyterian Hospital|