Clinical trial NCT01588054: Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity
Official title: Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Deformity
Kyphosis
Scoliosis
Lead sponsor: International Spine Study Group Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Spine
First posted: 2012-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: spine surgeon clinic

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.


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
* Prisoner
* Pregnant or planning to get pregnant during study period

Primary outcomes:
measure: Radiographs
timeFrame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
measure: Numeric rating scale (NRS)
timeFrame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
measure: CSRS SWAL-QOL
timeFrame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
measure: EQ-5D3L
timeFrame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
measure: mJOA
timeFrame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic La Jolla
state: California
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco Medical Center
state: California
city: Denver
country: United States
facility: Denver International Spine Center
state: Colorado
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University - Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Plano
country: United States
facility: Baylor Scoliosis Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
name: Justin Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: