Usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures: a monocenter randomized pilot study (ADEPTH-Pilot)

Usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures: a monocenter randomized pilot study (ADEPTH-Pilot) - ADEPTH-Pilot

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53499

Enrollment

Registered

2023-07-04

Start date

2023-08-22

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone fracture traumatic fracture

Interventions

In the intervention group, the surgeon uses the ADEPTH sensor for depth measurements during the operation. The hook is always present as a backup should the sensor malfunction. After the operation,

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli)(incl. delayed union, nonunion and malunion) Adults (>= 18 years) Needed surgical instrument net: 2.4/2.7/3.5-4.0/4.5-5.0-6.5 Written informed consent by patient

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
System Usability Score.	—

Secondary

Measure	Time frame
- Duration of the fixation process per screw, in seconds. - Implant waste.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)