Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06820736

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

Led by Twin Cities Spine Center · Updated on 2025-02-11

975

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

T

Twin Cities Spine Center

Lead Sponsor

A

Allina Health System

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand if using a drain after lumbar spine surgery can reduce recovery problems like infection or the need for further surgery. It focuses on patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion to treat lumbar stenosis and/or spondylolisthesis. The main goal is to compare the risk of returning to surgery within 90 days among different drainage methods. Participants will be randomly assigned to one of three groups: using a drain with compression suction, using a drain with gravity alone, or not using a drain at all. The drain is a small flexible tube placed next to the spine where the surgery occurred. The study will observe how these different drainage techniques affect recovery, including how long drains remain in place and any complications. During the study, researchers will monitor participants for up to 90 days after surgery. They will check for the need for reoperation, measure drain volume, track blood transfusions, length of hospital stay, and any complications. This thorough follow-up aims to provide detailed information on the safety and effects of different drainage methods after spinal surgery.

CONDITIONS

Brief Title

A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Hospital stay following surgery

Participants undergo one- or two-level open posterior lumbar decompression or decompression and fusion surgery. A drain may be placed depending on group assignment.

1 surgical visit and several in-hospital visits

Post-operative Follow-up

Duration - 90 days postoperatively

Participants are monitored for recovery, drain removal, and any complications including the need for reoperation within 90 days after surgery.

Approximately 6 post-operative visits

Trial Site Locations

Total: 1 location

1

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

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Research Team

J

John M Dawson, PhD

B

Berit A Swanberg

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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