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Evaluation of the Use of Resources and Costs

Primary Purpose

Surgical Incision

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Device O-Arm in DBS

Device O-Arm in RAQUIS

Not device O-Arm in DBS

Not device O-Arm in RAQUIS

About this trial

This is an interventional health services research trial for Surgical Incision focused on measuring deep brain surgery and complex back surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto de Investigación Sanitaria La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

O-Arm in deep brain stimulation surgeries (DBS)

Control group Not O-Arm in deep brain stimulation surgeries

O-Arm in complex back surgeries (RAQUIS)

Control group Not O-Arm in complex back surgeries (RAQUIS)

Arm Description

Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)

Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)

Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)

Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)

Outcomes

Primary Outcome Measures

Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with DBS (O-Arm and without O-Arm groups)

Costs of health resources (stays, visits, diagnostic and therapeutic tests, personnel, consumables and implants) with vertebral fusions (O-Arm and without O-Arm groups)

Secondary Outcome Measures

Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery

Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery

Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary

Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery

Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery

Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention

Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention

Full Information

NCT ID

NCT02989363

First Posted

November 29, 2016

Last Updated

December 7, 2016

Sponsor

Instituto de Investigacion Sanitaria La Fe

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT02989363

Brief Title

Evaluation of the Use of Resources and Costs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigacion Sanitaria La Fe

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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))

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Incision

Keywords

deep brain surgery and complex back surgery

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

O-Arm in deep brain stimulation surgeries (DBS)

Arm Type

Experimental

Arm Description

Use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)

Arm Title

Control group Not O-Arm in deep brain stimulation surgeries

Arm Type

Experimental

Arm Description

Not use of image surgery with technology O-Arm in deep brain stimulation surgeries (DBS)

Arm Title

O-Arm in complex back surgeries (RAQUIS)

Arm Type

Experimental

Arm Description

Use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)

Arm Title

Control group Not O-Arm in complex back surgeries (RAQUIS)

Arm Type

Experimental

Arm Description

Not use of image surgery with technology O-Arm in complex back surgeries (RAQUIS)

Intervention Type

Procedure

Intervention Name(s)

Device O-Arm in DBS

Intervention Description

Deep brain stimulation surgeries with device O-Arm

Intervention Type

Procedure

Intervention Name(s)

Device O-Arm in RAQUIS

Intervention Description

Complex back surgeries with the device O-Arm

Intervention Type

Procedure

Intervention Name(s)

Not device O-Arm in DBS

Intervention Description

Deep brain stimulation surgeries without the device O-Arm

Intervention Type

Procedure

Intervention Name(s)

Not device O-Arm in RAQUIS

Intervention Description

Complex back surgeries without the device O-Arm

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

Safety of surgeries in the control group (RAQUIS) measured like rate of complications associated with surgery

Time Frame

6 months

Title

Safety of surgeries in the intervention groups (DBS) measured like rate of complications associated with surgery

Time Frame

12 months

Title

Quality of life related to health in the intervention group (DBS) measured with the EQ-5D questionary

Time Frame

12 months

Title

Accuracy of surgeries in the control group (RAQUIS) measured with the rate of electrode or thyroid replacement during surgery

Time Frame

6 months

Title

Accuracy of surgeries in the intervention group (DBS) measured with the rate of electrode or thyroid replacement during surgery

Time Frame

12 months

Title

Safety of surgeries in the control group (RAQUIS) measured like rate rate of surgical re-intervention

Time Frame

6 months

Title

Safety of surgeries in the intervention groups (DBS) measured like rate of surgical re-intervention

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elena Garcia

Phone

0034961246711

investigacion_clinica@iislafe.es

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Segura

Phone

0034961246711

monitor1@iislafe.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Botella

Organizational Affiliation

Instituto de Investigación Sanitaria La Fe

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Investigación Sanitaria La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elena Garcia

Phone

34961246611

investigacion_clinica@iislafe.es

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Evaluation of the Use of Resources and Costs

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