Efficacy of Suction Enabled Retraction Device

April 23, 2019 updated by: Ian Cote, University of Miami

Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery

This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue

Elevator & Retractor [SISTER] device to assess:

  • Effects on operative time and efficiency of exposure in open lumbar spine cases.
  • Effect on total blood loss during the exposure part of the operation.
  • Rate of clogging of suction device.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The device, Suction-Integrated Surgical Tissue Elevator & Retractor [SISTER], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English speaking
  • Patients undergoing lumbar one to sacral one open instrumentation
  • Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine

Exclusion Criteria:

  • Less than 22 years old
  • Procedure does not involve instrumentation
  • Prior lumbar spine surgery involving more than one level
  • BMI less than 20 or greater than 35
  • Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
  • Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix)
  • Operative cases where a single surgeon performs both sides of exposure
  • Pregnant women
  • Prisoners
  • Adults unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use of Cobb device
Use of SISTER device during surgery
Device: SISTER device
Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery
Other Names:
  • Cobb
No Intervention: Control
Standard exposure technique and instruments will be used during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Blood Loss
Time Frame: 1.5 hours
Amount of blood loss from incision time to screw placement
1.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Exposure
Time Frame: 1.5 hours
Length of operation in minutes
1.5 hours
Rate of Clogging
Time Frame: 1.5 hours
Average number of times the suction tip of the device had to be unclogged
1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Ludwig Medical Corporation

Investigators

  • Principal Investigator: Ian Cõté, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

December 28, 2018

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20161061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data (IPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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