Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
NCT ID: NCT05960591
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-23
2024-12-31
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control
Participants will receive bore depth measurements with the manual depth gauge, which is the golden standard for bore depth measurements during plate osteosynthesis procedures.
No interventions assigned to this group
Intervention
Participants will receive bore depth measurements with the ADEPTH sensor, which is a new sensor technology for bore depth measurements during plate osteosynthesis procedures.
ADEPTH
ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
Interventions
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ADEPTH
ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Variable angle plates
* Corrective surgery after previous plate osteosynthesis procedure or hardware removal
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
SLAM Ortho B.V.
INDUSTRY
Responsible Party
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Locations
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Erasmus MC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Esther van Lieshout
Role: primary
Other Identifiers
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MEC-2023-0269
Identifier Type: -
Identifier Source: org_study_id
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