NCT05960591

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: SLAM Ortho B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fractures, Bone
• Osteosynthesis

Interventions

Type	Name	Description
DEVICE	ADEPTH	ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.

Timeline

• Start date: 2023-08-23
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-07-27
• Last updated: 2024-04-18

Locations

1 site across 1 country: Netherlands