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This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBG hip stem | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | Change in Harris Hip Score from Baseline to 10 years post surgery. The Harris Hip Score scales from 0-100 with higher values representing a better score. | Baseline and 10 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of position of hip stem | Change in hip stem position from Baseline to 10 years post surgery. | Baseline and 10 years post surgery |
| Radiographic Analysis: classification of osseointegration of hip stem |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Beat Schmid, Dr. med. | Praxis Klinik Gut Buchs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Klinik Gut Buchs | Buchs | Switzerland |
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| 10 years post surgery |
| Radiographic Analysis: radiolucent lines around hip stem | Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm. | 10 years post surgery |
| Radiographic Analysis: number of participants with femoral osteolysis around hip stem | 10 years post surgery |
| Radiographic Analysis: bone atrophy around hip stem | Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm. | 10 years post surgery |
| Radiographic Analysis: bone hypertrophy around hip stem | Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm. | 10 years post surgery |