Fractures, Bone, Osteosynthesis
Conditions
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.
Detailed 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.
Interventions
DEVICEADEPTH
ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
Sponsors
Erasmus Medical Center
SLAM Ortho B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis | Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months. | Used tool: System Usability Survey (SUS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Tool: Video system in OR, video recording of each participant. |
Countries
Netherlands
Contacts
Primary ContactRowan van der Peet, MSc
Outcome results
None listed