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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Twin Cities Spine Center
Study ID
NCT06820736
Status
Recruiting
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Conditions

  • Complications, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 10, 2025
Status verified
Feb 2025
Primary completion
Jan 9, 2035
Completion
Jan 9, 2040

Study Design

Enrollment
975 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Drain
    The drain will be used with compression suction.
  • Experimental: Passive Drain
    The drain will be used with gravity alone.
  • No Intervention: No Drain
    No drain will be used.

Primary Outcome Measure

Reoperation [ Time Frame: 90 days postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abbott Northwestern HospitalMinneapolisMinnesota55404
John M Dawson, PhD
[email protected]
612-775-6200
Berit A Swanberg
[email protected]
612-775-6200
Ben Mueller, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Abbott Northwestern Hospital· Minneapolis, MN