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Recruiting NCT05960591

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

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Trial Parameters

Condition Fractures, Bone
Sponsor SLAM Ortho B.V.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-23
Completion 2024-12
Interventions
ADEPTH

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Brief 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 Criteria

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

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