Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement
Recruitment status was Active, not recruiting
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Implant Survival Rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Descriptive Analysis of Adverse Event Frequency for the duration of the study.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: 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||Unafiliated|
|Study Director:||Genevieve d'Orsay, MD||DePuy|