A Personalised Percutaneous External 3D Guide for Scaphoid Fixation

Scaphoid Bone Fracture Clinical Trial

— Scaphix  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03502720
• Other study ID #: CSPTCOT2018533
• Status: Recruiting
• First received: April 11, 2018
• Last updated: April 20, 2018
• Start date: March 25, 2018
• Est. completion date: March 29, 2019

Study information

• Verified date: April 2018
• Source: Corporacion Parc Tauli
• Contact: Francesc A Marcano Fernandez, MD
• Phone: (34) 618023575
• Email: francescmarcano[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 29, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute scaphoid fracture (Herbert B1 B2)

Exclusion Criteria:

• Concomitant fractures

Related Conditions & MeSH terms

• Fractures, Bone
• Scaphoid Bone Fracture

Intervention

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)

Locations

Country	Name	City	State
Spain	Corporación sanitaria Parc Taulí de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screw Position	Correct position of screw inside of the scaphoid	1st day Xray
Secondary	Surgery time	time from beginning to completion of surgery	1st day
Secondary	xray exposure	radiation exposure during surgery	1st day