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

April 16, 2024 updated by: SLAM Ortho B.V.

Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Recruiting
        • Erasmus MC
        • Contact:
          • Esther van Lieshout

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
Time Frame: 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)
Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration in seconds of the fixation process per screw during plate osteosynthesis
Time Frame: 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.
In both study groups the operation will be recorded. Anticipated study duration is 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SLAM Ortho B.V.

Collaborators

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2023-0269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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