Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

Scoliosis Clinical Trial

— PCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588054
• Other study ID #: 2107-01
• Status: Completed
• Start date: January 9, 2013
• Est. completion date: June 2021

Study information

• Verified date: October 2023
• Source: International Spine Study Group Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Deformity
• Congenital Abnormalities
• Kyphosis
• Scoliosis

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Denver International Spine Center	Denver	Colorado
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Scripps Clinic La Jolla	La Jolla	California
United States	Hospital for Special Surgery	New York	New York
United States	New York University - Hospital for Joint Diseases	New York	New York
United States	Baylor Scoliosis Center	Plano	Texas
United States	University of California - Davis	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	University of California - San Francisco Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
International Spine Study Group Foundation	DePuy Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographs	Changes in the degree of deformity post surgical correction and assessment of fusion.	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary	Neck Disability Index (NDI)	Changes related to worsening/improved neck pain as regards ability to manage everyday life.	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary	Numeric rating scale (NRS)	Changes in level of neck and back pain within the past month	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary	CSRS SWAL-QOL	Changes with swallowing problems affecting day-to-day quality of life	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary	EQ-5D3L	Changes in current health state	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary	mJOA	Changes in neck pain regarding ability fo function in everyday life	Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop