July 23, 2015
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Federico P. Girardi, MD
Richard J. Herzog, MD, FACR
Andrew A. Sama, MD
Jennifer Shue, MS
Mohamed Moawad, BA
The clinical trial involves the application of AmnioFix, a Dehydrated Human Amnion/Chorion Membrane (dHACM), over the spinal cord during routine spinal lumbar decompression or microdiscectomy surgery. The formation of scar tissue in this area after this type of surgery may be responsible for recurrence of symptoms, failed back surgery syndrome, and may make repeat surgeries, if necessary, more difficult. The purpose of this study is to determine whether the application of AmnioFix will decrease the need for a second surgery and may make any second surgeries safer by decreasing the amount of scar tissue through which surgeons will have to dissect. This, in turn, may decrease the time, blood loss and other risks associated with any second spinal surgeries. Patients will be randomized to either receive AmnioFix or not receive AmnioFix during their scheduled lumbar spine surgery. A total of 224 patients will be enrolled for a study duration follow-up of 2 years.
Inclusion Criteria
• Patients over 18 years of age
• Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy or Patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
• Ability to provide full written consent
Exclusion Criteria
• Patients under the age 18 years of age
• Non-English speaking patients
• Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
• Patient allergic to aminoglycosides • Is a prisoner • Is involved in worker’s compensation or other litigation relative to the spine injury
• Has a history of drug or alcohol abuse within the last 12 months
• Is currently participating in another drug or device clinical trial
• Previous spinal surgery
• Patients with history of deformity, mechanical instability, or spinal fusion requirement
• History of hard- or soft-tissue spinal infection
• Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past
• Patients unable to undergo a MRI
• Patients unwilling or unable to return for routine follow-up or complete outcome instruments at the specified timepoints pre-and post-operatively
Mohamed Moawad, BA
moawadm@hss.edu
646.714.6516