Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study

Conditions
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Fractures, Bone, Osteosynthesis

Intervention / Treatment
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* Device: ADEPTH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli) (incl. delayed union, nonunion, malunion) Needed surgical instrument net: 2.4 / 2.7 / 3.5-4.0 / 4.5-5.0-6.5 Adults (≥ 18 years) Written informed consent by patient Exclusion Criteria: Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis) Variable angle plates Corrective surgery after previous plate osteosynthesis procedure or hardware removal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will receive bore depth measurements with the manual depth gauge, which is the golden standard for bore depth measurements during plate osteosynthesis procedures. | |
| Experimental: Intervention<br>Participants will receive bore depth measurements with the ADEPTH sensor, which is a new sensor technology for bore depth measurements during plate osteosynthesis procedures. | Device: ADEPTH<br>* ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.<br>* Other names: ADEPTH sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |