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

International Spine Study Group Foundation10 sites in 1 country100 target enrollmentJanuary 9, 2013

ConditionsCervical Deformity Kyphosis Scoliosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cervical Deformity
Sponsor: International Spine Study Group Foundation
Enrollment: 100
Locations: 10
Primary Endpoint: Radiographs
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 9, 2013

End Date

June 2021

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

International Spine Study Group Foundation

Responsible Party

Sponsor

Eligibility Criteria

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
•Pregnant or planning to get pregnant during study period

Outcomes

Primary Outcomes

Radiographs

Time Frame: 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 Outcomes

Neck Disability Index (NDI)(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
CSRS SWAL-QOL(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
Numeric rating scale (NRS)(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
mJOA(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
EQ-5D3L(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)