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The purpose of this randomised prospective multicenter longterm study is to evaluate the survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip Arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitelene | Plasmacup DC® with Vitelene® inlay manufactured by UHMWPE-XE (Ultra High Molecular Weight Polyethylene highly cross-linked with 0.1% Vitamin E) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®) |
| |
| XLPE | Plasmacup DC® with a standard polyethylene inlay manufactured by UHMWPE-X (Ultra High Molecular Weight Polyethylene highly cross-linked) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitelene | Device | THA |
| |
| XLPE |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision | The Oxidation index is measured after explantation in case of loosening of the inlay | Oxidation index is assessed in case of loosening and revision within 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Manifest radiological osteolyses | Measured radiologically after 1, 5, 10 and 15 years | |
| Traceable wear of polyethylene over 0.5 mm | Measured radiologically after 1, 5, 10 and 15 years | |
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Inclusion:
Exclusion:
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Jäger, Prof. Dr. med | Universitätsklinikum Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef | Bendorf | 56170 | Germany | |||
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Device |
THA |
|
| Clinical Outcome |
Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA) |
| After 1, 5, 10 and 15 years |
| Klinik für Orthopädie und Unfallchirurgie |
| Bochum |
| 44791 |
| Germany |
| Klinik und Poliklinik für Orthopädie | Halle | 06097 | Germany |
| Orthopädische Klinik der MHH im Annastift | Hanover | 30625 | Germany |
| St. Marien Hospital | Mülheim | Germany |
| Elisabeth Klinikum Olsberg | Olsberg | 59939 | Germany |