Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT

Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial

This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression.

While indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess stenosis. The current study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression. Enrolled participants will be evaluated before surgery, during their hospital course and post-operatively at 6 weeks, 3 months, 6 months, 1 and 2 years. Operative details, complications, reoperation rates, patient reported outcomes, clinical and radiographic outcome measures will be compared.

Inclusion Criteria:

• Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons:

  • Mobile degenerative spondylolisthesis
  • Severe vertical foraminal stenosis
  • Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain

• One-level central canal stenosis

  • WITH neurogenic claudication
  • As measured in preoperative MRI

• Oswestry Low Back Pain Disability Questionnaire score > 35% (18/50)

• Failed 3 months of conservative treatment

• Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms

Exclusion Criteria:

• Multilevel central canal stenosis
• Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage
• Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum
• Prior surgery at index disc level (discectomy, decompression, or fusion)
• History of spinal or vertebral infection of the lumbar spine
• History of vertebral fracture of the lumbar spine
• Current pregnancy or interest in becoming pregnant over the next 1 year
• Active infection-systemic or local
• Non-English speakers