A Personalised Percutaneous External 3D Guide for Scaphoid Fixation
- Conditions
- Scaphoid Bone Fracture
- Registration Number
- NCT03502720
- Lead Sponsor
- Corporacion Parc Tauli
- Brief 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.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Acute scaphoid fracture (Herbert B1 B2)
- Concomitant fractures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Screw Position 1st day Xray Correct position of screw inside of the scaphoid
- Secondary Outcome Measures
Name Time Method xray exposure 1st day radiation exposure during surgery
Surgery time 1st day time from beginning to completion of surgery
Trial Locations
- Locations (1)
Corporación sanitaria Parc Taulí de Sabadell
🇪🇸Sabadell, Barcelona, Spain
Corporación sanitaria Parc Taulí de Sabadell🇪🇸Sabadell, Barcelona, SpainFrancesc Marcano, DoctorContact00937231010famarcano@tauli.cat