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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Description

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.

Eligibility

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

Study details

Fractures, Bone, Osteosynthesis

NCT05960591

SLAM Ortho B.V.

29 April 2024

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