A Personalised Percutaneous External 3D Guide for Scaphoid Fixation

• Conditions: Scaphoid Bone Fracture
• Interventions: Procedure: Scaphoid fixation using standard procedure; Device: Scaphoid fixation using 3D device

• 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.

Study Timeline

• Study Start: 2018-03-25
• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-19
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-23
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Acute scaphoid fracture (Herbert B1 B2)

Exclusion Criteria

• Concomitant fractures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Patients	Scaphoid fixation using standard procedure	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.
Case Patients	Scaphoid fixation using 3D device	Prospective series of ten patients on which the external 3D guide system will be used.

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
Surgery time	1st day	time from beginning to completion of surgery
xray exposure	1st day	radiation exposure during surgery

Trial Locations

Locations (1)

Corporación sanitaria Parc Taulí de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain