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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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))
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O-Arm in deep brain stimulation surgeries (DBS) | Experimental | Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS) |
|
| Control group Not O-Arm in deep brain stimulation surgeries | Experimental | Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS) |
|
| O-Arm in complex back surgeries (RAQUIS) | Experimental | Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS) |
|
| Control group Not O-Arm in complex back surgeries (RAQUIS) | Experimental | Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device O-Arm in DBS | Procedure | Deep brain stimulation surgeries with device O-Arm |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Garcia | Contact | 0034961246711 | investigacion_clinica@iislafe.es | |
| Laura Segura | Contact | 0034961246711 | monitor1@iislafe.es |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Botella | Instituto de Investigación Sanitaria La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigación Sanitaria La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Device O-Arm in RAQUIS | Procedure | Complex back surgeries with the device O-Arm |
|
| Not device O-Arm in DBS | Procedure | Deep brain stimulation surgeries without the device O-Arm |
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| Not device O-Arm in RAQUIS | Procedure | Complex back surgeries without the device O-Arm |
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| 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 |