Arthropathy of Hip
Conditions
Brief summary
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.
Interventions
DEVICETotal Hip arthroplasty
Sponsors
DePuy International
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice
Exclusion criteria
* Patient refusal to participate to the data collection * Pregnant woman * Patients age is less than 18 years old * The planned intervention is a revision of a previous intervention on the studied hip joint * Previous metal implant, except for pure titanium or titanium alloys * Exposure to cobalt and chromium that could influence serum metal ions levels * Planned bilateral intervention * Patient residing outside France * Patient not implanted with a Pinnacle(R) ULTAMET(TM)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | pre-operative, 1, 2, 3, 5 years | Measure of hip function using the Harris Hip Score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cobalt and Chromium serum concentration | 3 to 6 Months, 1, 2, 3, 5 years | Descriptive analysis of patient serum concentration of Cobalt and Chromium |
| Adverse Event Frequency | Per-operative, 3 to 6 Months, 1, 2, 3, 5 years | Descriptive Analysis of Adverse Event Frequency for the duration of the study. |
Countries
France
Outcome results
None listed