NCT06820736NARecruiting
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
Twin Cities Spine Center
Start Date
1/10/2025
Completion Date
1/9/2040
Summary
This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
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.
Eligibility Criteria
Age Range: 18 years to 70 years
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
Interventions
DEVICE
Drain
Conditions
Complications, Postoperative
Locations
Abbott Northwestern Hospital
Minneapolis, Minnesota 55404
United States