Recruiting

Cervical Deformity

Sponsor:

International Spine Study Group Foundation

Code:

NCT04194996

Conditions

Cervical Deformity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical intervention

Study Details

Brief summary:

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

Conditions

Cervical Deformity

Study ID

NCT04194996

Start date

Aug 1, 2019

Status verified date

Feb, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Operative

Inclusion criteria:

1. ≥18 years old at time of treatment
2. 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
3. Plan for surgical correction of cervical deformity in the next 6 months

Interventions

Surgical intervention

Surgical interventions will be patient specified by treating surgeon.

Primary outcome measure

  • Pain Numeric rating scale (NRS) - Headaches [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Pain Numeric rating scale (NRS) - Neck [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Pain Numeric rating scale (NRS) - Upper extremity [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Pain Numeric rating scale (NRS) - Lower extremity [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Pain Numeric rating scale (NRS) - Back [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Neck Disability Index (NDI) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Depression [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Spine Radiographs [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]
  • Modified Japanese Orthopaedic Association Scale (mJOA) [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]

Central Contacts and Locations

Central contacts

Christine Baldus, MS

6184444130baldusc@wustl.edu

Ray Pinteric

ray.pinteric@outlook.com

Locations

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

Recruiting

La Jolla, California, United States, 92037

Contacts

Paulina de la Garza

858-554-7124delaGarza.Paulina@scrippshealth.org

Roslyn Kackman

Kackman.Roslyn@scrippshealth.org

Principal Investigator:

Robert Eastlack, MD

University of California-San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Adrian Fu

925-202-9682Adrian.Fu@ucsf.edu

Principal Investigator:

Christopher Ames, MD

Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80128

Contacts

Breton Line, BS

303.762.3472breton.line@gmail.com

Principal Investigator:

Shay Bess, MD

University of Kansas Medical Center, Department of Orthopedic Surgery

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Dave Turkowitch

dturkowitch@kumc.edu

Principal Investigator:

Brandon Carlson, MD

Leatherman Spine Center, Department of Orthopedic Surgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Morgan Brown

morgan.brown2@nortonhealthcare.org

Principal Investigator:

Jeffrey Gum, MD

Johns Hopkins University, Department of Neurological Surgery

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Ahmed Sulieman

asuliem2@jh.edu

Principal Investigator:

Khaled Kebaish, MD

Hospital for Special Surgery, Department of Orthopedic Surgery

Recruiting

New York, New York, United States, 10003

Contacts

Christopher Yoo

yooch@hss.edu

Principal Investigator:

Han Jo Kim, MD

New York University, Department of Orthopedic Surgery

Recruiting

New York, New York, United States, 10003

Contacts

Connie Maglaras

constance.maglaras@nyulangone.org

Principal Investigator:

Themistocles Protopsaltis, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Meghana Vulapalli

mv2748@cumc.columbia.edu

Principal Investigator:

Daniel K Riew, MD

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Ronald Pegues

ronald.pegues@duke.edu

Principal Investigator:

Christopher I Shaffrey, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Lauren Puccio

pucciolm@upmc.edu

Principal Investigator:

Thomas Buell, MD

Medical City Spine Hospital - Southwest Scoliosis Institute

Recruiting

Dallas, Texas, United States, 75243

Contacts

Mona Hedra, MD

214-663-5622Mona.Hedra@HCAhealthcare.com

Principal Investigator:

Richard Hostin, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Lorrie Sipe

434-924-8775lag3k@virginia.edu

Principal Investigator:

Justin Smith, MD

More Information

Sponsor

International Spine Study Group Foundation

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Cervical deformity
  • Kyphosis
  • Scoliosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by International Spine Study Group Foundation on 2026-02-17.