Evaluation of the Use of Resources and Costs

Instituto de Investigacion Sanitaria La Fe80 enrolled

Overview

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

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))

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Surgical Incision

Interventions

Device O-Arm in DBSPROCEDURE

Deep brain stimulation surgeries with device O-Arm

Device O-Arm in RAQUISPROCEDURE

Complex back surgeries with the device O-Arm

Not device O-Arm in DBSPROCEDURE

Deep brain stimulation surgeries without the device O-Arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto de Investigación Sanitaria La Fe

Valencia, Valencia, Spain

RECRUITING

Outcomes

Primary Outcomes

Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)

Time frame: 12 months

Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)

Time frame: 6 months

Secondary Outcomes

Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery

Time frame: 6 months

Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery

Time frame: 12 months

Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary

Time frame: 12 months

Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery

Time frame: 6 months

Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery

Time frame: 12 months

Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention

Time frame: 6 months

Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention

Time frame: 12 months

Central Contacts

Elena Garcia

CONTACT

0034961246711 investigacion_clinica@iislafe.es

Laura Segura

CONTACT

0034961246711 monitor1@iislafe.es

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.