Actively Recruiting

Age: 18Years +
All Genders
NCT04194996

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

Led by International Spine Study Group Foundation · Updated on 2026-02-17

200

Participants Needed

16

Research Sites

573 weeks

Total Duration

On this page

Sponsors

I

International Spine Study Group Foundation

Lead Sponsor

D

DePuy Synthes

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older at time of treatment
  • Diagnosis of cervical deformity meeting one or more of the following: C2-C7 sagittal kyphosis (Cobb > 15 degrees), T1S-CL > 35 degrees, segmental cervical kyphosis > 10 degrees between any 2 vertebrae between C2-T1 or > 15 degrees across any 3 vertebrae between C2-T1, cervical scoliosis > 10 degrees (Cobb angle within cervical spine), C2-C7 SVA > 4cm, McGregor's slope > 20 degrees or CBVA > 25 degrees
  • Planned revision surgery for proximal junctional failure with anticipated upper instrumented vertebra in cervical spine and lower instrumented vertebra in thoracic or lumbar spine
  • Plan for surgical correction of cervical deformity within next 6 months
  • Willing to provide consent and complete study forms at baseline and follow-ups
  • Upright AP/Lateral entire spine imaging (EOS or 36")
  • Upright AP/Lateral cervical spine imaging if cervical spine not fully visible on entire spine films
  • Flexion/extension lateral cervical spine imaging (exceptions allowed with documentation)
Not Eligible

You will not qualify if you...

  • Active spine tumor or infection
  • Deformity caused by acute trauma
  • Unwilling to provide consent or complete study forms
  • Prisoner status
  • Pregnant or immediate plans to become pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, United States, 92037

Actively Recruiting

2

University of California Davis, Department of Orthopedic Surgery

Sacramento, California, United States, 95817

Active, Not Recruiting

3

University of California-San Francisco Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

4

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

Denver, Colorado, United States, 80128

Actively Recruiting

5

Rush University, Department of Neurosurgery

Chicago, Illinois, United States, 60612

Withdrawn

6

University of Kansas Medical Center, Department of Orthopedic Surgery

Kansas City, Kansas, United States, 66160

Actively Recruiting

7

Leatherman Spine Center, Department of Orthopedic Surgery

Louisville, Kentucky, United States, 40202

Actively Recruiting

8

Johns Hopkins University, Department of Neurological Surgery

Baltimore, Maryland, United States, 21224

Actively Recruiting

9

University of Michigan, Department of Neurosurgery

Ann Arbor, Michigan, United States, 48109

Completed

10

Hospital for Special Surgery, Department of Orthopedic Surgery

New York, New York, United States, 10003

Actively Recruiting

11

New York University, Department of Orthopedic Surgery

New York, New York, United States, 10003

Actively Recruiting

12

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

13

Duke University Health System

Durham, North Carolina, United States, 27708

Actively Recruiting

14

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15219

Actively Recruiting

15

Medical City Spine Hospital - Southwest Scoliosis Institute

Dallas, Texas, United States, 75243

Actively Recruiting

16

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

C

Christine Baldus, MS

CONTACT

R

Ray Pinteric

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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