Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement
|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: NCT01684631|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment|
|Arthropathy of Hip||Device: Total Hip arthroplasty|
|Study Type :||Observational|
|Actual Enrollment :||107 participants|
|Official Title:||Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||December 2015|
Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.
Device: Total Hip arthroplasty
- Implant Survival Rate [ Time Frame: up to 5 years ]Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.
- Harris Hip Score [ Time Frame: pre-operative, 1, 2, 3, 5 years ]Measure of hip function using the Harris Hip Score
- Cobalt and Chromium serum concentration [ Time Frame: 3 to 6 Months, 1, 2, 3, 5 years ]Descriptive analysis of patient serum concentration of Cobalt and Chromium
- Adverse Event Frequency [ Time Frame: Per-operative, 3 to 6 Months, 1, 2, 3, 5 years ]Descriptive Analysis of Adverse Event Frequency for the duration of the study.
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): NCT01684631
|Aix-les-Bains, France, 73100|
|Ales, France, 30104|
|Centre Hospitalier Georges Renon|
|Niort, France, 79021|
|Clinique Saint Hilaire|
|Rouen, France, 76000|
|Royan, France, 17200|
|Clinique Mutualiste Saint Etienne|
|Saint Etienne, France, 42013|
|Principal Investigator:||Jean-Marie Toupin, MD||Clinique Saint Hilaire Rouen, France 76000|