A Prospective, Randomized Comparison of Drainage Techniques After One- or Two-Level Open Posterior Lumbar Decompression or Decompression and Fusion

Twin Cities Spine Center

Status: Enrolling

Conditions: Complications, Postoperative

Treatments: Device: Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT06820736

2199368-6

Details and patient eligibility

About

This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.

Full 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.

Enrollment: 975 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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975 participants in 3 patient groups

Active Drain

Experimental group

Description:

The drain will be used with compression suction.

Treatment:

Device: Drain

Passive Drain

Experimental group

Description:

The drain will be used with gravity alone.

Treatment:

Device: Drain

No Drain

No Intervention group

Description:

No drain will be used.