IRB Number: 13110

Institutional Review Board, Hospital for Special Surgery

February 11, 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

Darren R. Lebl, MD

Co-Investigators

Frank P. Cammisa, Jr, MD
James C. Farmer, MD
Federico P. Girardi, MD
Russel C. Huang, MD
Alexander P. Hughes, MD
Carol A. Mancuso, MD,FACP
Andrew A. Sama, MD
Harvinder S. Sandhu, MD
Jennifer Shue, MS

Summary

This study evaluates the efficacy of post-operative hard cervical collar wear in patients undergoing anterior cervical discectomy and fusion (ACDF) surgery of 3 or more levels. 60 patients will be enrolled in this study and the study follow-up period is 6 weeks after ACDF surgery.

Inclusion/Exclusion Criteria

Inclusion Criteria
 Patients at least 18 years old undergoing anterior cervical discectomy and fusion (ACDF) surgery of 3 or more levels.
 
Exclusion Criteria:
 Patients under 18 years of age
 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 ACDF surgery, the patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
 Patients unwilling or unable to complete PRO instruments or study questionnaires at the specified study timepoints pre- and post-operatively.
 Patients unable to tolerate hard cervical collar wear for a 2 to 6 week time period.

Contact Information

Darren R. Lebl, MD
lebeld@hss.edu
Phone: 212.606.1052