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

SLAM Ortho

Status: Enrolling

Conditions: Osteosynthesis; Fractures, Bone

Treatments: Device: ADEPTH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05960591

MEC-2023-0269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

No Intervention group

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.

Intervention

Experimental group

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.

Treatment:

Device: ADEPTH