Evaluating surgical treatment outcomes for cervical deformity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, prospective, non-randomized study aims to evaluate the outcomes of surgical interventions in patients with adult cervical deformity. The study focuses on various types of cervical deformities, including kyphosis and scoliosis, which can lead to significant neurological symptoms and functional disabilities. Participants will be assessed based on specific radiographic criteria and will undergo surgical correction within six months of enrollment. Data will be collected at baseline and follow-up intervals to analyze the effectiveness of the surgical treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years old at time of treatment
* Diagnosis of cervical deformity- must meet one or more of the following criteria:

  * C2-C7 sagittal kyphosis (Cobb \> 15 degrees)
  * T1S-CL \> 35o
  * Segmental cervical kyphosis \> 10 degrees between any 2 vertebra between C2-T1 or \> 15 degrees across any 3 vertebra between C2-T1
  * Cervical scoliosis \> 10 degrees (Cobb angle must include end vertebra within the cervical spine)
  * C2-C7 SVA \> 4cm
  * McGregor's slope \> 20 degrees or CBVA \> 25 degrees OR
  * Planned Revision surgery for proximal junctional failure with an anticipated UIV in the cervical spine and an anticipated LIV in the thoracic or lumbar spine.
* Plan for surgical correction of cervical deformity in the next 6 months
* Willing to provide consent and complete study forms at baseline and follow-up intervals
* Upright AP/Lateral entire spine (EOS or 36")
* Upright AP/Lateral C spine ONLY IF C spine is not completely visible on entire spine films
* Flex/Ext lateral C spine. Admin may allow exceptions w/ valid documentation.

Exclusion Criteria:

* Active spine tumor or infection
* Deformity due to acute trauma
* Unwilling to provide consent or to complete study forms
* Prisoner
* Pregnant or immediate plans to get pregnant

Where it's running

• Shiley Center for Orthopaedic Research and Education at Scripps Clinic
  La Jolla, California, United States Recruiting
• University of California-San Francisco Medical Center
  San Francisco, California, United States Recruiting
• Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
  Denver, Colorado, United States Recruiting
• University of Kansas Medical Center, Department of Orthopedic Surgery
  Kansas City, Kansas, United States Recruiting
• Leatherman Spine Center, Department of Orthopedic Surgery
  Louisville, Kentucky, United States Recruiting
• Johns Hopkins University, Department of Neurological Surgery
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Justin Smith, MD — University of Virginia, Department of Neurosurgery
• Study coordinator: Christine Baldus, MS
• Email: baldusc@wustl.edu
• Phone: 6184444130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.