IRB Number: 14002

Institutional Review Board, Hospital for Special Surgery

May 08, 2014

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.

Principal Investigator

Alexander P. Hughes, MD

Co-Investigators

Manjula Basnsal, MD
Adele Boskey, PhD
Federico P. Girardi, MD
Andrew A. Sama, MD
Theodore T. Miller, MD

Summary

The purpose of this study is to determine if ultrasound can be used to assess collagen changes and its relationship to bone and tissue quality. Currently, there are no accurate, non-invasive methods to determine this.  Collagen is a common component of bone and other tissue that supports and binds other tissues in your body. The hypothesis that skin collagen could be used to predict the state of bone has been proposed based on similar changes between bone and skin with age, disease, and hormones. This pilot study will determine the degree such relationships exist, if the quality of tissue examined can be determined in a non-invasive way, and how these findings affect spine surgery outcomes. A total of 60 patients will be enrolled for participation up to 1 year after surgery

Inclusion/Exclusion Criteria

Inclusion Criteria

 Patients undergoing instrumented, posterior lumbar fusion (PLF)

Exclusion Criteria

 Patients under 18 years of age
 Previous fusion surgery at the level(s) to be treated
 Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: the patient does not meet the indications for PLF surgery, the patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
 Patients unwilling or unable to return for evaluation at the specified study timepoints pre- and post-operatively
 Have cognitive deficits and cannot provide consent

Contact Information

Alexander P. Hughes, MD
hughesa@hss.edu
212.774.2992