Clinical trial NCT02989363: Evaluation of the Use of Resources and Costs
Official title: Evaluation of the Use of Resources and Costs With O-arm in Brain Stimulation Deep Surgeries and Complex Back Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Incision
Keywords: deep brain surgery and complex back surgery
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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))

Eligibility criteria: 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.

Primary outcomes:
measure: Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
timeFrame: 12 months
measure: Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)
timeFrame: 6 months
Secondary outcomes:
measure: Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery
timeFrame: 6 months
measure: Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery
timeFrame: 12 months
measure: Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary
timeFrame: 12 months
measure: Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery
timeFrame: 6 months
measure: Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery
timeFrame: 12 months
measure: Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention
timeFrame: 6 months
measure: Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto de Investigación Sanitaria La Fe
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe
name: Carlos Botella
role: PRINCIPAL_INVESTIGATOR
References: