Evaluation of the Use of Resources and Costs

Evaluation of the Use of Resources and Costs With O-arm in Brain Stimulation Deep Surgeries and Complex Back Surgeries

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02989363

Enrollment

Registered

2016-12-12

Start date

2011-10-31

Completion date

2017-12-31

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Incision

Keywords

deep brain surgery and complex back surgery

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))

Interventions

PROCEDUREDevice O-Arm in DBS

Deep brain stimulation surgeries with device O-Arm

PROCEDUREDevice O-Arm in RAQUIS

Complex back surgeries with the device O-Arm

PROCEDURENot device O-Arm in DBS

Deep brain stimulation surgeries without the device O-Arm

PROCEDURENot device O-Arm in RAQUIS

Complex back surgeries without the device O-Arm

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)	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)	6 months

Secondary

Measure	Time frame
Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary	12 months
Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery	6 months
Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery	6 months
Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention	6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention	12 months
Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery	12 months
Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery	12 months

Countries

Spain

Contacts

Primary ContactElena Garcia

investigacion_clinica@iislafe.es0034961246711

Backup ContactLaura Segura

monitor1@iislafe.es0034961246711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026