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

Sponsor
SLAM Ortho B.V. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05960591
Collaborator
Erasmus Medical Center (Other)
60
Enrollment
2
Arms
5
Anticipated Duration (Months)

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Device: ADEPTH
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized in either the control group (bore depth measurement with the manual depth gauge) or in the intervention group (bore depth measurements with the ADEPTH sensor).Participants will be randomized in either the control group (bore depth measurement with the manual depth gauge) or in the intervention group (bore depth measurements with the ADEPTH sensor).
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Participants will receive bore depth measurements with the manual depth gauge, which is the golden standard for bore depth measurements during plate osteosynthesis procedures.
Experimental: Intervention

Participants will receive bore depth measurements with the ADEPTH sensor, which is a new sensor technology for bore depth measurements during plate osteosynthesis procedures.

Device: ADEPTH
ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
Other Names:
  • ADEPTH sensor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis [Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months.]

      Used tool: System Usability Survey (SUS)

    Secondary Outcome Measures

    1. Duration in seconds of the fixation process per screw during plate osteosynthesis [In both study groups the operation will be recorded. Anticipated study duration is 6 months.]

      Tool: Video system in OR, video recording of each participant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • SLAM Ortho B.V.
    • Erasmus Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SLAM Ortho B.V.
    ClinicalTrials.gov Identifier:
    NCT05960591
    Other Study ID Numbers:
    • MEC-2023-0269
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Jul 27, 2023