RecruitingNot ApplicableNCT05960591

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


Sponsor

SLAM Ortho B.V.

Enrollment

60 participants

Start Date

Aug 23, 2023

Study Type

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

Min Age: 18 Years

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

DEVICEADEPTH

ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.


Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT05960591


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