Comparing drainage techniques after lumbar spine surgery
A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion
This study is testing if using drainage tubes after lumbar spine surgery can help reduce complications and the need for more surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 975 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Twin Cities Spine Center Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06820736 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of drainage techniques in reducing postoperative complications following one- or two-level open posterior lumbar decompression or decompression and fusion. The study will prospectively assess the relative risk of patients needing to return to the operating room within 90 days post-surgery. By comparing outcomes between patients with and without drains, the research seeks to determine if drains can minimize issues such as infections or the necessity for additional surgeries.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for one- or two-level open spinal decompression or decompression and fusion due to lumbar stenosis or spondylolisthesis.
Not a fit: Patients with infections, tumors, trauma, or those who have had prior lumbar fusion surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes and reduced complications for patients undergoing lumbar spine surgery.
How similar studies have performed: Previous studies have explored drainage techniques in surgical settings, but this specific comparison in lumbar spine surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ben Mueller, MD, PhD — Twin Cities Spine Center
- Study coordinator: John M Dawson, PhD
- Email: RSRCH1@tcspine.com
- Phone: 612-775-6200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.