Scaphoid Bone FractureScaphixNCT03502720
A Personalised Percutaneous External 3D Guide for Scaphoid Fixation
An observational study of Scaphoid Bone Fracture, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scaphoid Bone Fracture
- What is being tested?
- Scaphoid fixation using 3D device and Scaphoid fixation using standard procedure
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2018to 29 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Patients with an Scaphoid acute fracture that requires surgery
Who may be able to join
- Acute scaphoid fracture (Herbert B1 B2)
Who cannot join
- Concomitant fractures
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Corporación sanitaria Parc Taulí de Sabadell
Sabadell, Barcelona, 08208
Francesc Marcano, Doctor, 00937231010, famarcano@tauli.cat
About this study
Official title: Analysis of a Customized Percutaneous External Guidance System for Scaphoid Fracture Fixation Using 3D Printing
The investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.
The investigators hypothesise that the usage of this device will shorten surgery time, radiation for the surgery team and optimise the percutaneous screw trajectory inside of the scaphoid bone.
Read the detailed description
To carry out this analysis the investigators will recruit 10 patients who present with an acute fracture of the Scaphoid bone type B1 and B2 (Herbert Classification).
A CT Scan will be performed and a 3D exoesqueleton model printed, previously deciding the position of the fixation screw inside of the bone and adding a cannulated sleeve in the volar aspect of the exoesqueleton to insert the initial positional guide wire for surgery.
Surgery time, surgery radiation exposure and screw positioning will be recorded and compared to 10 control patients operated following standard procedure.
- Conditions
- Scaphoid Bone Fracture
- Being tested
- Scaphoid fixation using 3D device, Scaphoid fixation using standard procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaphoid fixation using 3D deviceDevice
A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner using a customised 3D exoesqueleton guide
Scaphoid fixation using standard procedureProcedure or surgery
A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner without using the 3D device (standard procedure)
| Study group | Role | What they receive |
|---|---|---|
| Control Patients | Data obtained retrospectively from Scaphoid fixation surgeries performed at our center using the standard procedure (no device for guide wire positioning).
This control group should have registered al parameters and variables to be studied. Receives: Procedure: Scaphoid fixation using standard procedure | |
| Case Patients | Prospective series of ten patients on which the external 3D guide system will be used. Receives: Device: Scaphoid fixation using 3D device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw Position
Correct position of screw inside of the scaphoid
Measured: 1st day Xray
Secondary outcomes (2)
Surgery time
time from beginning to completion of surgery
Measured: 1st day
xray exposure
radiation exposure during surgery
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start25 Mar 2018
- Primary completion25 Mar 2019 (estimated)
- Study completion29 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid Bone FractureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesc A. Marcano-Fernández, Corporacion Parc Tauli
- Investigators
- Francesc A Marcano Fernandez, MD, Principal investigator, Hospital parc tauli Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502720
- Sponsor's protocol ID
- CSPTCOT2018533
- Acronym
- Scaphix
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of a Customized Percutaneous External Guidance System for Scaphoid Fracture Fixation Using 3D Printing
- ClinicalTrials.gov ID
- NCT03502720
- Acronym / sponsor ID
- Scaphix / CSPTCOT2018533
- Conditions
- Scaphoid Bone Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 25 Mar 2019 (estimated)
- Study completion
- 29 Mar 2019 (estimated)
- First posted
- 19 Apr 2018 (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 investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.
The investigators hypothesise that the usage of this device will shorten surgery time, radiation for the surgery team and optimise the percutaneous screw trajectory inside of the scaphoid bone.
Detailed description
To carry out this analysis the investigators will recruit 10 patients who present with an acute fracture of the Scaphoid bone type B1 and B2 (Herbert Classification).
A CT Scan will be performed and a 3D exoesqueleton model printed, previously deciding the position of the fixation screw inside of the bone and adding a cannulated sleeve in the volar aspect of the exoesqueleton to insert the initial positional guide wire for surgery.
Surgery time, surgery radiation exposure and screw positioning will be recorded and compared to 10 control patients operated following standard procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Patients | – | Procedure: Scaphoid fixation using standard procedureData obtained retrospectively from Scaphoid fixation surgeries performed at our center using the standard procedure (no device for guide wire positioning). This control group should have registered al parameters and variables to be studied. |
| Case Patients | – | Device: Scaphoid fixation using 3D deviceProspective series of ten patients on which the external 3D guide system will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an Scaphoid acute fracture that requires surgery
Key inclusion criteria (1 listed)
- Acute scaphoid fracture (Herbert B1 B2)
Key exclusion criteria (1 listed)
- Concomitant fractures
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 |
|---|---|---|
| Scaphoid fixation using 3D deviceA headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner using a customised 3D exoesqueleton guide | Device | Case Patients |
| Scaphoid fixation using standard procedureA headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner without using the 3D device (standard procedure) | Procedure or surgery | Control Patients |
Primary outcome
Screw Position
Time frame: 1st day Xray
Correct position of screw inside of the scaphoid
2 secondary outcomes
Surgery time
Time frame: 1st day
xray exposure
Time frame: 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Francesc A Marcano Fernandez, MD principal investigator
Hospital parc tauli Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scaphoid Bone Fracture, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 1 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 23 Apr 2018. 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 Spain. 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 Francesc A Marcano Fernandez, MD ((34) 618023575, francescmarcano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screw Position (time frame: 1st day Xray). 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 23 Apr 2018.