Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
SLAM Ortho B.V.
60 participants
Aug 23, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
- Variable angle plates
- Corrective surgery after previous plate osteosynthesis procedure or hardware removal
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Interventions
ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05960591