Evaluation of the Use of Resources and Costs

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989363
• Other study ID #: Study ECOPRES
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2016
• Last updated: December 7, 2016
• Start date: October 2011
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Elena Garcia
• Phone: 0034961246711
• Email: investigacion_clinica[@]iislafe.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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))

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Surgical Incision

Intervention

Procedure:
• Device O-Arm in DBS
Deep brain stimulation surgeries with device O-Arm
• Device O-Arm in RAQUIS
Complex back surgeries with the device O-Arm
• Not device O-Arm in DBS
Deep brain stimulation surgeries without the device O-Arm
• Not device O-Arm in RAQUIS
Complex back surgeries without the device O-Arm

Locations

Country	Name	City	State
Spain	Instituto de Investigación Sanitaria La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe	Medtronic

Country where clinical trial is conducted

Spain, 

Outcome

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