Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

Completed

• Conditions: Cervical Deformity; Scoliosis; Kyphosis

• Registration Number: NCT01588054
• Lead Sponsor: International Spine Study Group Foundation

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Study Start: 2013-01-09
• Primary Completion: 2021-05-08
• Study Completion: 2021-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographs	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop	Changes in the degree of deformity post surgical correction and assessment of fusion.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop	Changes related to worsening/improved neck pain as regards ability to manage everyday life.
CSRS SWAL-QOL	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop	Changes with swallowing problems affecting day-to-day quality of life
Numeric rating scale (NRS)	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop	Changes in level of neck and back pain within the past month
mJOA	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop	Changes in neck pain regarding ability fo function in everyday life
EQ-5D3L	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop	Changes in current health state

Trial Locations

Locations (10)

Baylor Scoliosis Center; 🇺🇸 Plano, Texas, United States

Denver International Spine Center; 🇺🇸 Denver, Colorado, United States

University of California - Davis; 🇺🇸 Sacramento, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

University of California - San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

New York University - Hospital for Joint Diseases; 🇺🇸 New York, New York, United States

Scripps Clinic La Jolla; 🇺🇸 La Jolla, California, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States