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Group 1: Postoperative Drain Group for Lumbar Fusion

N/A
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age \> 18
* Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression. The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain

Who is the study for?
This trial is for patients undergoing primary lumbar fusion surgery. It's designed to see if using a drain after the operation helps or not. People with certain health conditions that could affect their participation are excluded, but specific criteria aren't listed here.
What is being tested?
The study compares outcomes of lumbar fusion surgery between two groups: one has a postoperative drain placed to prevent fluid buildup and complications; the other does not use a drain.
What are the potential side effects?
Potential side effects may include risk of infection from drains, increased blood loss, longer hospital stays, and higher costs. Not using drains might increase the risk of hematoma and related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of postoperative complications

Trial Design

2Treatment groups
Active Control
Group I: Group 1: Postoperative Drain GroupActive Control1 Intervention
Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively
Group II: Group 2: No Postoperative Drain GroupActive Control1 Intervention
Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively

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Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
124 Previous Clinical Trials
21,830 Total Patients Enrolled
~133 spots leftby Aug 2025
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