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

NCT ID: NCT05960591

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Fractures, Bone Osteosynthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

ADEPTH

Intervention Type DEVICE

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

Interventions

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ADEPTH

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

Intervention Type DEVICE

Other Intervention Names

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ADEPTH sensor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

SLAM Ortho B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Rowan van der Peet, MSc

Role: CONTACT

0614308291

Facility Contacts

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Esther van Lieshout

Role: primary

Other Identifiers

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MEC-2023-0269

Identifier Type: -

Identifier Source: org_study_id

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