Evaluation of the Use of Resources and Costs

Instituto de Investigacion Sanitaria La Fe

Status: Unknown

Conditions: Surgical Incision

Treatments: Procedure: Not device O-Arm in RAQUIS; Procedure: Device O-Arm in RAQUIS; Procedure: Device O-Arm in DBS; Procedure: Not device O-Arm in DBS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02989363

Study ECOPRES

Details and patient eligibility

About

Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS) surgeries and complex back surgeries

Full description

To measure the use of health resources in application A (with DBS) and in application B (vertebral fusions), in patients in the intervention group with O-arm and in the control group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical, post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥18 years.
• Signed informed consent.
• Patients with indication for DBS surgery for movement disorders, epilepsy and obsessive-compulsive disorder, or for cervical, dorsal or lumbar fusion surgery levels 1,2 and 3 in a degenerative disease

Exclusion criteria

• Patients who have had pediatric instrumented surgery.
• Patients in which the pedicle screws are inserted for neoplasia or other disease.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

O-Arm in deep brain stimulation surgeries (DBS)

Experimental group

Description:

Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)

Treatment:

Procedure: Device O-Arm in DBS

Control group Not O-Arm in deep brain stimulation surgeries

Experimental group

Description:

Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)

Treatment:

Procedure: Not device O-Arm in DBS

O-Arm in complex back surgeries (RAQUIS)

Experimental group

Description:

Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)

Treatment:

Procedure: Device O-Arm in RAQUIS

Control group Not O-Arm in complex back surgeries (RAQUIS)

Experimental group

Description:

Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)

Treatment:

Procedure: Not device O-Arm in RAQUIS