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

Last updated: April 16, 2024
Sponsor: SLAM Ortho B.V.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ADEPTH

Clinical Study ID

NCT05960591
MEC-2023-0269
  • Ages > 18
  • All Genders

Study 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

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

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 Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: ADEPTH
Phase:
Study Start date:
August 23, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Erasmus MC

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Active - Recruiting

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