Clinical trial NCT06820736: A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
Official title: A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complications, Postoperative
Keywords: Lumbar spine surgery
drain
postoperative complications
Lead sponsor: Twin Cities Spine Center
Sponsor class: OTHER
Collaborators: name: Allina Health System
First posted: 2025-02-11
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reoperation
timeFrame: 90 days postoperatively
Secondary outcomes:
measure: Time to drain removal
timeFrame: 90 days postoperatively
measure: Drain volume
timeFrame: 90 days postoperatively
measure: Transfusion
timeFrame: 90 days postoperatively
measure: Length of Stay
timeFrame: 90 days postoperatively
measure: Complications
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Twin Cities Spine Center
name: Ben Mueller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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