Institutional Review Board, Hospital for Special Surgery
March 06, 2007
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.
A total of 102 subjects will participate in this study for a period of one year. Follow-up phone calls will take place at 1 week, 1 month, 3 months, 6 months, and 1 year after the initial injection.
Inclusion criteria will be patients with clinical symptoms of primarily axial lower back pain accompanied by buttock or thigh pain (greater than 80% of their pain in the back or buttocks as opposed to their legs) and radiologic evidence of Grade 1-2 lumbar degenerative spondylolisthesis. Rating scales to determine the level and grade of spondylolisthesis include slip percent and Meyerding’s grade.
Exclusion criteria will include patients with isthmic spondylolisthesis or fracture-related degenerative spondylolisthesis, progressive neurologic signs and symptoms, radicular pain, patients with pain radiating below the knees, severe central and foraminal spinal stenosis as graded by relative central lumbar spinal canal diameters on MRI imaging, higher grades of lumbar degenerative spondylolisthesis, severe zygapophyseal joint arthritis, disk herniation, facet synovial cysts, any history of lumbar spine surgery at the involved levels, lumbar epidural injections within the last 3 months, pregnancy, active infection, active coagulopathy, and patients younger than 18 years of age.