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Evaluation of the Use of Resources and Costs

NCT ID: NCT02989363

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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))

Conditions

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Surgical Incision

Keywords

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deep brain surgery and complex back surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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O-Arm in deep brain stimulation surgeries (DBS)

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

Group Type EXPERIMENTAL

Device O-Arm in DBS

Intervention Type PROCEDURE

Deep brain stimulation surgeries with device O-Arm

Control group Not O-Arm in deep brain stimulation surgeries

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

Group Type EXPERIMENTAL

Not device O-Arm in DBS

Intervention Type PROCEDURE

Deep brain stimulation surgeries without the device O-Arm

O-Arm in complex back surgeries (RAQUIS)

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

Group Type EXPERIMENTAL

Device O-Arm in RAQUIS

Intervention Type PROCEDURE

Complex back surgeries with the device O-Arm

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

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

Group Type EXPERIMENTAL

Not device O-Arm in RAQUIS

Intervention Type PROCEDURE

Complex back surgeries without the device O-Arm

Interventions

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Device O-Arm in DBS

Deep brain stimulation surgeries with device O-Arm

Intervention Type PROCEDURE

Device O-Arm in RAQUIS

Complex back surgeries with the device O-Arm

Intervention Type PROCEDURE

Not device O-Arm in DBS

Deep brain stimulation surgeries without the device O-Arm

Intervention Type PROCEDURE

Not device O-Arm in RAQUIS

Complex back surgeries without the device O-Arm

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Botella

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Sanitaria La Fe

Locations

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Instituto de Investigación Sanitaria La Fe

Valencia, Valencia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Elena Garcia

Role: CONTACT

Phone: 0034961246711

Email: [email protected]

Laura Segura

Role: CONTACT

Phone: 0034961246711

Email: [email protected]

Facility Contacts

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Elena Garcia

Role: primary

Other Identifiers

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Study ECOPRES

Identifier Type: -

Identifier Source: org_study_id