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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02989363
Other study ID # Study ECOPRES
Secondary ID
Status Recruiting
Phase N/A
First received November 29, 2016
Last updated December 7, 2016
Start date October 2011
Est. completion date December 2017

Study information

Verified date November 2016
Source Instituto de Investigacion Sanitaria La Fe
Contact Elena Garcia
Phone 0034961246711
Email investigacion_clinica@iislafe.es
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

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


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))


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Procedure:
Device O-Arm in DBS
Deep brain stimulation surgeries with device O-Arm
Device O-Arm in RAQUIS
Complex back surgeries with the device O-Arm
Not device O-Arm in DBS
Deep brain stimulation surgeries without the device O-Arm
Not device O-Arm in RAQUIS
Complex back surgeries without the device O-Arm

Locations

Country Name City State
Spain Instituto de Investigación Sanitaria La Fe Valencia

Sponsors (2)

Lead Sponsor Collaborator
Instituto de Investigacion Sanitaria La Fe Medtronic

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery 6 months No
Secondary Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery 12 months No
Secondary Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary 12 months No
Secondary Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery 6 months No
Secondary Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery 12 months No
Secondary Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention 6 months No
Secondary Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention 12 months No
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