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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03502720

Acronym

Scaphix

Enrollment

Registered

2018-04-19

Start date

2018-03-25

Completion date

2019-03-29

Last updated

2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scaphoid Bone Fracture

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.

Interventions

DEVICEScaphoid 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

PROCEDUREScaphoid 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)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Acute scaphoid fracture (Herbert B1 B2)

Exclusion criteria

* Concomitant fractures

Design outcomes

Primary

Measure	Time frame	Description
Screw Position	1st day Xray	Correct position of screw inside of the scaphoid

Secondary

Measure	Time frame	Description
Surgery time	1st day	time from beginning to completion of surgery
xray exposure	1st day	radiation exposure during surgery

Countries

Spain

Contacts

Primary ContactFrancesc A Marcano Fernandez, MD

francescmarcano@gmail.com(34) 618023575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026