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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.
60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bonemaster | Experimental | Cement-less femoral stems with electrochemical deposition of hydroxyapatite |
|
| Hydroxyapatite | Active Comparator | Cement-less femoral stems with plasmasprayed hydroxyapatite |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taperloc | Device | Femoral stem with electrochemical deposition of hydroxyapatite |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early and intermediate periprosthetic bone remodeling | Bone densitometry measured by DXA | 5 years |
| Early and intermediate femoral stem stability | Radiostereometric analysis of femoral stem movements relative to bone | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical function | Hip questionares, Harris Hip Score and Oxford Hip Score | 5 years |
| Radiographic signs of loosening | Conventional x-ray |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364953 | Derived | Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 5 years |
| D012216 |
| Rheumatic Diseases |