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

IRB Number: 2019 - 2228

November 17, 2020

Institutional Review Board, Hospital for Special Surgery

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Principal Investigator

Sravisht Iyer, MD

Co-Investigators

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

Summary

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

Inclusion:
   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

Exclusion:
  o Multilevel central canal stenosis
  o BMI >40
 

Contact Information

Research Manager:
Evangelia Zgonis
zgonise@hss.edu
917.260.4602

Research Coordinator:
Tianna Bennett
bennettt@hss.edu
212.774.2674