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slow enrollment
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| Name | Class |
|---|---|
| Biomet U.K. Ltd. | INDUSTRY |
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Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.
A single type of femoral component with 3 different HA coatings will be evaluated in this study. Patients with fractured neck of femur requiring hemi-arthroplasty will be recruited. Safety and performance of the device will be determined by adverse events (device related or non-related), survival and histological exam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA |
|
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA | Device | Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Anytime |
| Measure | Description | Time Frame |
|---|---|---|
| Histological Exam | Anytime |
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Inclusion Criteria:
Exclusion criteria:
• None
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| Name | Affiliation | Role |
|---|---|---|
| Helmut Zahn, FRCS | William Harvey Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Harvey Hospital | Ashford | Kent | United Kingdom |
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| Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA | Device | Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA |
|
| Hip stem with Interloc Titanium surface + Bonemaster H.A | Device | Hip stem with Interloc Titanium surface + Bonemaster H.A |
|
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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