NCT02989363

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 12, 2016

Status Verified

November 1, 2016

Enrollment Period

6.2 years

First QC Date

November 29, 2016

Last Update Submit

December 7, 2016

Conditions

Surgical Incision

Keywords

deep brain surgery and complex back surgery

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (7)

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (4)

O-Arm in deep brain stimulation surgeries (DBS)

EXPERIMENTAL

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

Procedure: Device O-Arm in 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)

Procedure: Not device O-Arm in DBS

O-Arm in complex back surgeries (RAQUIS)

EXPERIMENTAL

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

Procedure: Device O-Arm in 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)

Procedure: Not device O-Arm in RAQUIS

Interventions

Device O-Arm in DBSPROCEDURE

Deep brain stimulation surgeries with device O-Arm

O-Arm in deep brain stimulation surgeries (DBS)
Device O-Arm in RAQUISPROCEDURE

Complex back surgeries with the device O-Arm

O-Arm in complex back surgeries (RAQUIS)
Not device O-Arm in DBSPROCEDURE

Deep brain stimulation surgeries without the device O-Arm

Control group Not O-Arm in deep brain stimulation surgeries
Not device O-Arm in RAQUISPROCEDURE

Complex back surgeries without the device O-Arm

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have had pediatric instrumented surgery.
  • Patients in which the pedicle screws are inserted for neoplasia or other disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Investigación Sanitaria La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Carlos Botella

    Instituto de Investigación Sanitaria La Fe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Garcia

CONTACT

0034961246711investigacion_clinica@iislafe.es

Laura Segura

CONTACT

0034961246711monitor1@iislafe.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 12, 2016

Study Start

October 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 12, 2016

Record last verified: 2016-11

Locations

ES(1)