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

C

Corporacion Parc Tauli

Status

Unknown

Conditions

Scaphoid Bone Fracture

Treatments

Procedure: Scaphoid fixation using standard procedure
Device: Scaphoid fixation using 3D device

Study type

Observational

Funder types

Other

Identifiers

NCT03502720
CSPTCOT2018533

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Acute scaphoid fracture (Herbert B1 B2)

Exclusion criteria

  • Concomitant fractures

Trial design

20 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Francesc A Marcano Fernandez, MD

Data sourced from clinicaltrials.gov

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