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

During osteosynthesis operations, surgeons currently use a manual depth gauge
(a hook) to manually measure the drilling depth after drilling in order to
determine the correct screw length. Surgeons have indicated that the bracket is
not always accurate enough and that using the bracket often takes a long time.
To solve this, SLAM Orthopedics has developed the ADEPTH sensor that
automatically measures the drilling depth during drilling. In this way, the
manual measuring step is eliminated, which can save time. In addition, the
ADEPTH sensor is more accurate than the hook, which reduces the chance of the
wrong length of the screw. In this study we want to know how the surgeon thinks
the ADEPTH sensor works, so we are curious about the usability of the ADEPTH.
This first pilot study in the clinic is necessary to further develop the ADEPTH
to meet the needs of the surgeon in the future and to improve patient care.
This first in-clinic pilot study is necessary to further improve the ADEPTH
sensor in order to improve future patient care and to provide in the surgeon's
needs to replace the manual depth gauge.

Primary Objective:
- To assess the usability score of the ADEPTH sensor for bore depth
measurements during elective plate osteosynthesis procedures in adults.

Secondary Objective:
- To compare the duration of the fixation process per screw between the control
group and intervention group.
- To compare implant waste between the control group and intervention group.

Monocenter, randomized pilot study.

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, the surgeon and the OR
assistant receive a short questionnaire (SUS survey) about the use of the
ADEPTH sensor. There will be no further changes to the care or treatment for
the patient.

Trauma surgeons will perform the plate osteosynthesis procedures according to
standard of care. The ADEPTH sensor is tested on safety, performance and
sterility before the start of the pilot study. The additional risk of using the
ADEPTH sensor during plate osteosynthesis procedures is considered very low,
since the workflow is not changed and the DG will always be available for
backup. Surgeons and OR assistants will be trained before the start of the
study and will be asked to fill in one survey after three plate osteosynthesis
procedures. There is no extra burden, nor an increased risk for the patient.
Possible benefits for the patient could be the higher accuracy of the ADEPTH
sensor, causing less re-operations. In addition, the time saving component
could reduce the duration of the procedures which could lead to a lower
infection rate.