An interventional study of Device O-Arm in DBS and Device O-Arm in RAQUIS in Surgical Incision, sponsored by Instituto de Investigacion Sanitaria La Fe. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-12.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Not applicable, Interventional, and Health services research
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))
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)
Procedure: Device O-Arm in DBS
Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)
Procedure: Not device O-Arm in DBS
Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)
Procedure: Device O-Arm in RAQUIS
Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)
Procedure: Not device O-Arm in RAQUIS
Deep brain stimulation surgeries with device O-Arm
Complex back surgeries with the device O-Arm
Deep brain stimulation surgeries without the device O-Arm
Complex back surgeries without the device O-Arm
Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)
Time frame: 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)
Time frame: 6 months
Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery
Time frame: 6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery
Time frame: 12 months
Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary
Time frame: 12 months
Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery
Time frame: 6 months
Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery
Time frame: 12 months
Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention
Time frame: 6 months
Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Instituto de Investigacion Sanitaria La Fe