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

Fractures, Bone Clinical Trial

— ADEPTH-Pilot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960591
• Other study ID #: MEC-2023-0269
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: SLAM Ortho B.V.
• Contact: Rowan van der Peet, MSc
• Phone: 0614308291
• Email: rowanvanderpeet[@]slamortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteosynthesis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
SLAM Ortho B.V.	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis	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	Duration in seconds of the fixation process per screw during plate osteosynthesis	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.