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

NCT05960591 | Recruiting

• 1 other identifier: MEC-2023-0269
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone; Osteosynthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Interventions

ADEPTH DEVICE

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

Also known as: ADEPTH sensor

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
• Variable angle plates
• Corrective surgery after previous plate osteosynthesis procedure or hardware removal

Sponsors & Collaborators

• SLAM Ortho B.V.: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Rowan van der Peet, MSc

CONTACT

0614308291; rowanvanderpeet@slamortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 27, 2023
• Study Start: August 23, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)