Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

NCT ID: NCT01588054

Last Updated: 2023-10-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-09

Study Completion Date

2021-06-30

Brief Summary

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The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.

Detailed Description

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Conditions

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Cervical Deformity Kyphosis Scoliosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

* Adult 18 years of age or greater
* 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

* Active tumor or infection
* Acute trauma
* Unwillingness to provide consent or complete study forms
* Prisoner
* Pregnant or planning to get pregnant during study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Spine

INDUSTRY

Sponsor Role collaborator

International Spine Study Group Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of California - Davis

Sacramento, California, United States

Site Status

University of California - San Francisco Medical Center

San Francisco, California, United States

Site Status

Denver International Spine Center

Denver, Colorado, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

New York University - Hospital for Joint Diseases

New York, New York, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Baylor Scoliosis Center

Plano, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 39752660 (View on PubMed)

Other Identifiers

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2107-01

Identifier Type: -

Identifier Source: org_study_id

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