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The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Sealant Vapor-Heated Solvent/Detergent-treated | Drug |
Inclusion Criteria:
Each subject to be included into the study must fulfill the following inclusion criteria:
Exclusion Criteria:
Subjects fulfilling the following exclusion criteria will not be recruited into the study:
Also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Florian Gottsauner-Wolf, MD | A. ö. Krankenhaus Krems, Austria | Principal Investigator |
| Axel Rüter, MD | Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A. ö. Krankenhaus Krems, Abteilung f. Orthopädie | Krems | Lower Austria | 3500 | Austria | ||
| Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics |
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| Vienna |
| 1090 |
| Austria |
| Donauspital im SMZ Ost, Department of Orthopedic Surgery | Vienna | 1220 | Austria |
| Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg | Augsburg | 86156 | Germany |
| St. Anna Ziekenhuis, Orthopedic Surgery | Geldrop | 5664 | Netherlands |
| Academisch Ziekenhuis Maastricht, Orthopedic Surgery | Maastricht | 6229 | Netherlands |
| St. Clara Ziekenhuis, Orthopedic Surgery | Rotterdam | 3078 | Netherlands |
| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
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