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HSS Research Institute

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

IRB Number: 2019 - 2228

Institutional Review Board, Hospital for Special Surgery

November 17, 2020

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For further information, see Understanding Clinical Trials.

Principal Investigator

Sravisht Iyer, MD


Sheeraz Qureshi, MD, MBA
Andre Samuels, MD
Kyle Morse, MD
Shafi Karim, MD
Evangelia Zgonis
Tianna Bennett


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 moderate central and lateral recess stenosis. The current study seeks
to randomize 80 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
postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 year. Operative
details, complications, reoperation rates, patient reported outcomes, clinical and
radiographic outcome measures will be compared.

Inclusion/Exclusion Criteria

   o Fusion indicated by the treating surgeon 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

   o One-level central canal stenosis WITH neurogenic claudication
   o Oswestry Low Back Pain Disability Questionnaire score > 35% (18/50)
   o Failed 3 months of conservative treatment

  o Multilevel central canal stenosis
  o BMI >40


Contact Information

Research Manager:
Evangelia Zgonis

Research Coordinator:
Tianna Bennett