Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip arthroplasty | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip arthroplasty | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause. | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | Measure of hip function using the Harris Hip Score | pre-operative, 1, 2, 3, 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cobalt and Chromium serum concentration | Descriptive analysis of patient serum concentration of Cobalt and Chromium | 3 to 6 Months, 1, 2, 3, 5 years |
| Adverse Event Frequency | Descriptive Analysis of Adverse Event Frequency for the duration of the study. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients susceptible to receive a PINNACLE® ULTAMET™ implant
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Marie Toupin, MD | Clinique Saint Hilaire Rouen, France 76000 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Herbert | Aix-les-Bains | 73100 | France | |||
| Clinique Bonnefon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5783851 | Background | Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
| Per-operative, 3 to 6 Months, 1, 2, 3, 5 years |
| Alès |
| 30104 |
| France |
| Centre Hospitalier Georges Renon | Niort | 79021 | France |
| Clinique Saint Hilaire | Rouen | 76000 | France |
| Clinique Pasteur | Royan | 17200 | France |
| Clinique Mutualiste Saint Etienne | Saint-Etienne | 42013 | France |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |