A Personalised Percutaneous External 3D Guide for Scaphoid Fixation (Scaphix)

April 20, 2018 updated by: Francesc A. Marcano-Fernández, Corporacion Parc Tauli

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Corporación sanitaria Parc Taulí de Sabadell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an Scaphoid acute fracture that requires surgery

Description

Inclusion Criteria:

  • Acute scaphoid fracture (Herbert B1 B2)

Exclusion Criteria:

  • Concomitant fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Patients

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.
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)
Case Patients
Prospective series of ten patients on which the external 3D guide system will be used.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Francesc A Marcano Fernandez, MD, Hospital Parc Tauli Sabadell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2018

Primary Completion (Anticipated)

March 25, 2019

Study Completion (Anticipated)

March 29, 2019

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPTCOT2018533

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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