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

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