Institutional Review Board, Hospital for Special Surgery
November 17, 2020
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
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:
o Fusion indicated by the treating surgeon for one or more of the following reasons:
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
Research Manager:
Evangelia Zgonis
zgonise@hss.edu
917.260.4602
Research Coordinator:
Tianna Bennett
bennettt@hss.edu
212.774.2674