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Completed

NCT Number: NCT01588054

Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

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.

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Key information

Conditions

Cervical Deformity Bone Diseases Kyphosis Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Clinic La Jolla, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Neck Disability Index (NDI)

    Time frame: 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.

  2. Numeric rating scale (NRS)

    Time frame: 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

  3. CSRS SWAL-QOL

    Time frame: 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

  4. EQ-5D3L

    Time frame: 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

  5. mJOA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

International Spine Study Group Foundation

Other

Collaborators

  • DePuy Spine

Registry information

Official study title

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

Acronym: PCD

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2012
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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