NCT06820736 · Twin Cities Spine Center
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
What this study is about
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
View original scientific description
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
Interventions
DEVICE
Drain
A drain is a small flexible tube that is placed next to where the spine was operated upon.
Primary outcome measures
Reoperation
Time frame: 90 days postoperatively
Relative risk of return to the operating room
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Collaborators
Allina Health System
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations