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The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hollow Centralizer | Active Comparator | The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. |
|
| Solid Centralizer | Active Comparator | The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hollow Centralizer | Procedure | The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer |
| Measure | Description | Time Frame |
|---|---|---|
| Radiostereometric Analysis (RSA) | This will measure the change in stem migration over time and be indicative of long term result. | The first postoperative day, 6 months, 1, 2, 5 and 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| x-ray | On standard x-rays the progress of radiolucent lines or other signs of loosening will be measured | The first postoperative day, 6 months, 1, 2, 5 and 10 years |
| Hip specific questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, Skane University Hospital, Lund University | Lund | Skåne County | 221 85 | Sweden |
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| Solid Centralizer | Procedure | The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer |
|
| MS-30 femoral stem | Device | This is the stem used in the study. |
|
Hip disability and Osteoarthritis Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients hip function and pain situation
| Preoperatively, 1, 2, 5 and 10 years |
| General health questionnaire | EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome | Preoperatively, 1, 2, 5 and 10 years |