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Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

RecruitingObservational study

Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

What is being tested

Surgical intervention (procedure)

Sponsor: International Spine Study Group Foundation · Participants: 200 · Started: Aug 1, 2019

Contact the study team

Christine Baldus, MS · Phone: 6184444130

Official record on ClinicalTrials.gov — NCT04194996

Locations in the U.S.

California	Shiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla University of California-San Francisco Medical Center, San Francisco
Colorado	Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center, Denver
Kansas	University of Kansas Medical Center, Department of Orthopedic Surgery, Kansas City
Kentucky	Leatherman Spine Center, Department of Orthopedic Surgery, Louisville
Maryland	Johns Hopkins University, Department of Neurological Surgery, Baltimore
New York	Columbia University Medical Center, New York Hospital for Special Surgery, Department of Orthopedic Surgery, New York New York University, Department of Orthopedic Surgery, New York
North Carolina	Duke University Health System, Durham
Pennsylvania	University of Pittsburgh Medical Center, Pittsburgh
Texas	Medical City Spine Hospital - Southwest Scoliosis Institute, Dallas
Virginia	University of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.