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

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

Study Overview

• Status: Unknown
• Conditions: Surgical Incision
• Intervention / Treatment: Procedure: Device O-Arm in DBS; Procedure: Not device O-Arm in DBS; Procedure: Device O-Arm in RAQUIS; Procedure: Not device O-Arm in RAQUIS

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))

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • Instituto de Investigación Sanitaria La Fe
    • Contact: Elena Garcia; Phone Number: 34961246611; Email: investigacion_clinica@iislafe.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: O-Arm in deep brain stimulation surgeries (DBS); Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)	Procedure: Device O-Arm in DBS; Deep brain stimulation surgeries with device O-Arm
Experimental: 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)	Procedure: Not device O-Arm in DBS; Deep brain stimulation surgeries without the device O-Arm
Experimental: O-Arm in complex back surgeries (RAQUIS); Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)	Procedure: Device O-Arm in RAQUIS; Complex back surgeries with the device O-Arm
Experimental: Control group Not O-Arm in complex back surgeries (RAQUIS); Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)	Procedure: Not device O-Arm in RAQUIS; Complex back surgeries without the device O-Arm

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery	6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery	12 months
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
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 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

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Collaborators: Medtronic
• Investigators: Principal Investigator: Carlos Botella, Instituto de Investigación Sanitaria La Fe

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Estimate): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 7, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: deep brain surgery and complex back surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: Study ECOPRES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided