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This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.
Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Treatment with investigational method (virtual implant positioning system) |
|
| B | Other | Treatment with surgical standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with investigational method (virtual implant positioning system) | Procedure |
| ||
| Treatment with surgical standard of care |
| Measure | Description | Time Frame |
|---|---|---|
| Number of screw replacements in both treatments arms | The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B) | Participants will be followed for the duration of the hospital stay, an expected average of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the investigational method to the standard of care regarding radiation time. | Participants will be followed for the duration of the hospital stay, an expected average of 3 days | |
| Number of adverse events and serious adverse events during the clinical investigarion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kleinszig Gerhard, MSc | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siemens AG Healthcare Sector | Erlangen | 91052 | Germany |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Procedure |
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| Participants will be followed for the duration of the hospital stay, an expected average of 3 days |