Institutional Review Board, Hospital for Special Surgery
March 31, 2009
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.
Spinal fusion is a common surgery to alleviate specific types of back pain. In patients undergoing a spinal fusion surgery, it is often necessary to remove bone from somewhere and transfer it to the spine where it will form the bony fusion between levels of the spine that eliminates motion and reduces pain. This bone is called “bone graft.” The most common part of the body where surgeons obtain bone graft is a region on the lower back called the iliac crest. Previous studies have suggested that some patients have pain at site where bone graft is obtained. The purpose of this study is to determine how much pain patients have at the site where bone graft is obtained for spinal fusion. To test this, the study will look at adults undergoing a spinal fusion of the low back. Specifically, it will look at the bottom two levels of the low back. This region is called the lumbar spine. The iliac crest will be accessed through the same incision used for the spinal fusion. Participants will be blinded to which side of the body bone graft was harvested from. They will then be asked to record the amount of pain they are experiencing over the right and left iliac crests at 6 weeks, 3 months, 6 months and 12 months after surgery. Your overall participation will be over a period of 1 year.
The study will include:
Patients age 18 to 75 undergoing elective spinal fusion for one or two levels between L4 and S1 for spinal stenosis with or without spondylolisthesis.
The study will exclude:
1. Non-surgical candidate: Any patient deemed by the surgeon not to be a surgical candidate cannot participate. Reasons could include: patient does not meet indications for surgery, or patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
2. Bilateral harvest: Any patients who require bilateral iliac crest harvesting will be excluded.
3. Prior harvest: Patients who have previously undergone posterior iliac crest harvesting will be excluded.
4. Spinopelvic fixation: Patients who require the insertion of instrumentation into the ilium itself will be excluded.
5. Abnormality of iliac crest: Any patient with an abnormality of either iliac crest that the surgeon would normally consider a contraindication to bone graft harvesting of that side, such as preexisting tumor, infection, or dysplasia, would be excluded.
Grant Shifflett, MD