Fractures, BoneADEPTH-PilotNCT05960591
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
A study testing ADEPTH in people with Fractures, Bone and Osteosynthesis, run by SLAM Ortho B.V. at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone, Osteosynthesis
- What is being tested?
- ADEPTH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Aug 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
- Variable angle plates
- Corrective surgery after previous plate osteosynthesis procedure or hardware removal
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
Esther van Lieshout
About this study
Official title: Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
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.
Read the 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.
- Conditions
- Fractures, Bone, Osteosynthesis
- Being tested
- ADEPTH
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADEPTHDevice
Also called ADEPTH sensor
ADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ADEPTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
Used tool: System Usability Survey (SUS)
Measured: 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
Tool: Video system in OR, video recording of each participant.
Measured: In both study groups the operation will be recorded. Anticipated study duration is 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start23 Aug 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SLAM Ortho B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960591
- Sponsor's protocol ID
- MEC-2023-0269
- Acronym
- ADEPTH-Pilot
- Status last verified
- Apr 2024
- First submitted
- 7 Jul 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05960591
- Acronym / sponsor ID
- ADEPTH-Pilot / MEC-2023-0269
- Conditions
- Fractures, Bone, Osteosynthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SLAM Ortho B.V.Industry (pharma, biotech, devices)
- Collaborators
- Erasmus Medical Center
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: ADEPTHParticipants will receive bore depth measurements with the ADEPTH sensor, which is a new sensor technology for bore depth measurements during plate osteosynthesis procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
- Variable angle plates
- Corrective surgery after previous plate osteosynthesis procedure or hardware removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADEPTHAlso: ADEPTH sensorADEPTH sensor will be used for bore depth measurements during plate osteosynthesis procedures. | Device | Intervention |
Primary outcome
Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
Time frame: 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)
1 secondary outcome
Duration in seconds of the fixation process per screw during plate osteosynthesis
Time frame: In both study groups the operation will be recorded. Anticipated study duration is 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADEPTH in people with Fractures, Bone and Osteosynthesis, run by SLAM Ortho B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rowan van der Peet, MSc (0614308291, rowanvanderpeet@slamortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis (time frame: Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.