A Personalised Percutaneous External 3D Guide for Scaphoid Fixation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Scaphoid Bone Fracture

Intervention / Treatment
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* Device: Scaphoid fixation using 3D device
* Procedure: Scaphoid fixation using standard procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute scaphoid fracture (Herbert B1 B2) Exclusion Criteria: Concomitant fractures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Patients<br>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<br>* A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner without using the 3D device (standard procedure)<br>|
| Case Patients<br>Prospective series of ten patients on which the external 3D guide system will be used. | Device: Scaphoid fixation using 3D device<br>* A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner using a customised 3D exoesqueleton guide<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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