NCT06820736

A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 975 (estimated)
• Sponsor: Twin Cities Spine Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complications, Postoperative

Interventions

Type	Name	Description
DEVICE	Drain	A drain is a small flexible tube that is placed next to where the spine was operated upon.

Timeline

• Start date: 2025-01-10
• Primary completion: 2035-01-09
• Completion: 2040-01-09
• First posted: 2025-02-11
• Last updated: 2025-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study