NCT06820736RecruitingNot Applicable
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
Twin Cities Spine Center1 site in 1 country975 target enrollmentStarted: January 10, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 975
- Locations
- 1
- Primary Endpoint
- Reoperation
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active Drain
Experimental
The drain will be used with compression suction.
Intervention: Drain (Device)
Passive Drain
Experimental
The drain will be used with gravity alone.
Intervention: Drain (Device)
No Drain
No Intervention
No drain will be used.
Outcomes
Primary Outcomes
Reoperation
Time Frame: 90 days postoperatively
Relative risk of return to the operating room
Secondary Outcomes
- Time to drain removal(90 days postoperatively)
- Length of Stay(90 days postoperatively)
- Complications(90 days postoperatively)
- Drain volume(90 days postoperatively)
- Transfusion(90 days postoperatively)
Investigators
Study Sites (1)
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