Surgical Incision Clinical Trial
Official title:
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
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. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Spain | Instituto de Investigación Sanitaria La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigacion Sanitaria La Fe | Medtronic |
Spain,
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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