NCT03502720

A Personalised Percutaneous External 3D Guide for Scaphoid Fixation

Analysis of a Customized Percutaneous External Guidance System for Scaphoid Fracture Fixation Using 3D Printing

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scaphoid Bone Fracture

Interventions

Type	Name	Description
DEVICE	Scaphoid fixation using 3D device	A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner using a customised 3D exoesqueleton guide
PROCEDURE	Scaphoid fixation using standard procedure	A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner without using the 3D device (standard procedure)

Timeline

• Start date: 2018-03-25
• Primary completion: 2019-03-25
• Completion: 2019-03-29
• First posted: 2018-04-19
• Last updated: 2018-04-23

Locations

1 site across 1 country: Spain