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

Primary Purpose

Fractures, Bone, Osteosynthesis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ADEPTH
Sponsored by
SLAM Ortho B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fractures, Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
    Used tool: System Usability Survey (SUS)

    Secondary Outcome Measures

    Duration in seconds of the fixation process per screw during plate osteosynthesis
    Tool: Video system in OR, video recording of each participant.

    Full Information

    First Posted
    July 7, 2023
    Last Updated
    July 17, 2023
    Sponsor
    SLAM Ortho B.V.
    Collaborators
    Erasmus Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960591
    Brief Title
    Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
    Acronym
    ADEPTH-Pilot
    Official Title
    Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SLAM Ortho B.V.
    Collaborators
    Erasmus Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fractures, Bone, Osteosynthesis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants will receive bore depth measurements with the manual depth gauge, which is the golden standard for bore depth measurements during plate osteosynthesis procedures.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will receive bore depth measurements with the ADEPTH sensor, which is a new sensor technology for bore depth measurements during plate osteosynthesis procedures.
    Intervention Type
    Device
    Intervention Name(s)
    ADEPTH
    Other Intervention Name(s)
    ADEPTH sensor
    Intervention Description
    ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
    Primary Outcome Measure Information:
    Title
    Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
    Description
    Used tool: System Usability Survey (SUS)
    Time Frame
    Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months.
    Secondary Outcome Measure Information:
    Title
    Duration in seconds of the fixation process per screw during plate osteosynthesis
    Description
    Tool: Video system in OR, video recording of each participant.
    Time Frame
    In both study groups the operation will be recorded. Anticipated study duration is 6 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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