A Prospective, Randomized Comparison of Drainage Techniques After One- or Two-Level Open Posterior Lumbar Decompression or Decompression and Fusion

February 5, 2025 updated by: Twin Cities Spine Center
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.

Study Type

Interventional

Enrollment (Estimated)

975

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
        • Contact:
        • Contact:
          • Ben Mueller, MD, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis

Exclusion Criteria:

  • Infection, tumor, or trauma
  • Prior lumbar fusion surgery
  • Lumbar fusion surgery at more than 2 levels
  • Anterior lumbar surgery
  • Perioperative anticoagulation treatment
  • Intraoperative incidental durotomy
  • Intraoperative or postoperative cerebrospinal fluid leakage
  • Intraoperative EBL greater than one liter

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Drain
The drain will be used with compression suction.
Device: Drain
A drain is a small flexible tube that is placed next to where the spine was operated upon.
Experimental: Passive Drain
The drain will be used with gravity alone.
Device: Drain
A drain is a small flexible tube that is placed next to where the spine was operated upon.
No Intervention: No Drain
No drain will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: 90 days postoperatively
Relative risk of return to the operating room
90 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to drain removal
Time Frame: 90 days postoperatively
Time (minutes) to drain removal
90 days postoperatively
Drain volume
Time Frame: 90 days postoperatively
Daily volume (mL) of fluid collected by the drain
90 days postoperatively
Transfusion
Time Frame: 90 days postoperatively
Need (yes or no) for a postoperative transfusion
90 days postoperatively
Length of Stay
Time Frame: 90 days postoperatively
Length of hospital stay
90 days postoperatively
Complications
Time Frame: 90 days postoperatively
Occurrence (yes/no) of wound complications, wound dehiscence, superficial wound infection or deep wound inflection
90 days postoperatively

Collaborators and Investigators

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

Sponsor

Twin Cities Spine Center

Collaborators

Allina Health System

Investigators

  • Principal Investigator: Ben Mueller, MD, PhD, Twin Cities Spine Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 10, 2025

Primary Completion (Estimated)

January 9, 2035

Study Completion (Estimated)

January 9, 2040

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2199368-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not want to share 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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