Registry for Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

Clinical Trial Title

Prospective radiographic and clinical evaluation of surgical treatment for cervical deformity: A multi-center study.

National Clinical Trial Number:

NCT04194996

Clinical Trial Protocol Description:

The registry aims to collect data on multicenter, prospective, nonrandomized analysis of operatively treated adult cervical deformity (ACD) patients.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are at least 18 years of age at the time of treatment.
  • Have a diagnosis of cervical deformity. Must meet one or more of the following criteria:
    • C2-C7 sagittal kyphosis (Cobb > 15o)
    • T1S-CL > 35o
    • Segmental cervical kyphosis > 10o between any 2 vertebra between C2-T1 or > 15o across any 3 vertebra between C2-T1
    • Cervical scoliosis > 10o (Cobb angle must include end vertebra within the cervical spine)
    • C2-C7 SVA > 4cm
    • McGregor’s slope > 20 degrees or CBVA > 25 degrees
  • Plan for surgical correction of cervical deformity in the next 6 months.
  • Are willing to provide consent and complete study forms at baseline and follow-up intervals.

You will be excluded from the study if any of the following criteria apply to you:

  • Have active spine tumor or infection.
  • Have deformity due to acute trauma.
  • Are unwilling to provide consent or to complete study forms.
  • Are a prisoner.
  • Are pregnant or have immediate plans to get pregnant.

This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Vincent Traynelis, MD

Contact Information

Ewa Gliwa