Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01588054

Acronym

PCD

Enrollment

100

Registered

2012-04-30

Start date

2013-01-09

Completion date

2021-06-30

Last updated

2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Deformity, Kyphosis, Scoliosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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
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
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
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

Countries

United States

Outcome results