Evaluating surgical treatment outcomes for cervical deformity
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
This study is testing how well different surgeries can help adults with neck deformities, like kyphosis and scoliosis, feel better and improve their function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | International Spine Study Group Foundation Academic / other |
| Locations | 16 sites (La Jolla, California and 15 other locations) |
| Trial ID | NCT04194996 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with cervical deformity who are planning surgical correction within the next six months.
Not a fit: Patients with active spine tumors, infections, or deformities due to acute trauma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients suffering from cervical deformities.
How similar studies have performed: While there is a lack of high-quality studies specifically addressing cervical deformity, similar approaches in thoracolumbar deformities have shown success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
La Jolla, California and 15 other locations
- Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States (Recruiting)
- University of California Davis, Department of Orthopedic Surgery — Sacramento, California, United States (Active_not_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)
- Rush University, Department of Neurosurgery — Chicago, Illinois, United States (Withdrawn)
- 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)
- University of Michigan, Department of Neurosurgery — Ann Arbor, Michigan, United States (Completed)
- Hospital for Special Surgery, Department of Orthopedic Surgery — New York, New York, United States (Recruiting)
- New York University, Department of Orthopedic Surgery — New York, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- Duke University Health System — Durham, North Carolina, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical City Spine Hospital - Southwest Scoliosis Institute — Dallas, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.