Evaluation of the Use of Resources and Costs

Study Overview
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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))

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

Conditions
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Surgical Incision

Intervention / Treatment
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* Procedure: Device O-Arm in DBS
* Procedure: Device O-Arm in RAQUIS
* Procedure: Not device O-Arm in DBS
* Procedure: Not device O-Arm in RAQUIS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep brain surgery and complex back surgery