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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
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The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The main question it aims to answer is:
- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures? Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge.
To assess the usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The surgeon and OR-assistant will fill in one survey after performing 3 operations with the ADEPTH sensor and one survey after performing 3 operations with the manual depth gauge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants will receive bore depth measurements with the manual depth gauge, which is the golden standard for bore depth measurements during plate osteosynthesis procedures. | |
| Intervention | Experimental | Participants will receive bore depth measurements with the ADEPTH sensor, which is a new sensor technology for bore depth measurements during plate osteosynthesis procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADEPTH | Device | ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis | Used tool: System Usability Survey (SUS) | Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration in seconds of the fixation process per screw during plate osteosynthesis | Tool: Video system in OR, video recording of each participant. | In both study groups the operation will be recorded. Anticipated study duration is 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rowan van der Peet, MSc | Contact | 0614308291 | rowanvanderpeet@slamortho.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Participants will be randomized in either the control group (bore depth measurement with the manual depth gauge) or in the intervention group (bore depth measurements with the ADEPTH sensor).
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