Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity
NCT ID: NCT01588054
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2013-01-09
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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adults, cervical deformity, surgical treatment
Adults 18years or older at time of enrollment, cervical deformity to include kyphosis (C2-7 greater than 10 degrees) or scoliosis (coronal cobb greater than 10 degrees), plans for surgical treatment of cervical deformity
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees)
* Plans for surgical correction of cervical deformity
Exclusion Criteria
* Acute trauma
* Unwillingness to provide consent or complete study forms
* Prisoner
* Pregnant or planning to get pregnant during study period
18 Years
ALL
No
Sponsors
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DePuy Spine
INDUSTRY
International Spine Study Group Foundation
OTHER
Responsible Party
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Principal Investigators
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Justin Smith, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Scripps Clinic La Jolla
La Jolla, California, United States
University of California - Davis
Sacramento, California, United States
University of California - San Francisco Medical Center
San Francisco, California, United States
Denver International Spine Center
Denver, Colorado, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Washington University
St Louis, Missouri, United States
New York University - Hospital for Joint Diseases
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Baylor Scoliosis Center
Plano, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Smith JS, Ben-Israel D, Kelly MP, Lafage V, Lafage R, Klineberg EO, Kim HJ, Line B, Protopsaltis TS, Passias P, Eastlack RK, Mundis GM, Riew KD, Kebaish K, Park P, Gupta MC, Gum JL, Daniels AH, Diebo BG, Hostin R, Scheer JK, Soroceanu A, Hamilton DK, Buell TJ, Lewis SJ, Lenke LG, Mullin JP, Schwab FJ, Burton D, Shaffrey CI, Ames CP, Bess S. The gap between surgeon goal and achieved sagittal alignment in adult cervical spine deformity surgery. J Neurosurg Spine. 2025 Jan 3;42(3):309-319. doi: 10.3171/2024.8.SPINE24703. Print 2025 Mar 1.
Other Identifiers
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2107-01
Identifier Type: -
Identifier Source: org_study_id
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