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A Randomized Controlled Investigation of Post-operative Collar Wear in One- to Two-Level Anterior Cervical Discectomy and Fusion (ACDF) Surgery Patients

IRB Number: 13149

May 08, 2014

Institutional Review Board, Hospital for Special Surgery

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Principal Investigator

Darren R. Lebl, MD


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


This study evaluates the efficacy of post-operative hard cervical collar wear in patients undergoing anterior cervical discectomy and fusion (ACDF) surgery of 1-2 levels. 120 patients will be enrolled in this study and the study follow-up period is 6 months after ACDF surgery.

Inclusion/Exclusion Criteria

Inclusion Criteria
• Patients at least 18 years old undergoing anterior cervical discectomy and fusion (ACDF) surgery of 1-2 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 week time period.

Contact Information

Darren R. Lebl, MD