NCT01588054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

January 9, 2013

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

8.3 years

First QC Date

April 24, 2012

Last Update Submit

October 11, 2023

Conditions

Cervical DeformityKyphosisScoliosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Neck Disability Index (NDI)

    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

  • CSRS SWAL-QOL

    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

  • mJOA

    Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop

Study Arms (1)

adults, cervical deformity, surgical treatment

Adults 18years or older at time of enrollment, cervical deformity to include kyphosis (C2-7 greater than 10 degrees) or scoliosis (coronal cobb greater than 10 degrees), plans for surgical treatment of cervical deformity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

spine surgeon clinic

You may qualify if:

  • 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

You may not qualify if:

  • Active tumor or infection
  • Acute trauma
  • Unwillingness to provide consent or complete study forms
  • Prisoner
  • Pregnant or planning to get pregnant during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Scripps Clinic La Jolla

La Jolla, California, 92037, United States

Location

University of California - Davis

Sacramento, California, 95817, United States

Location

University of California - San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Denver International Spine Center

Denver, Colorado, 80128, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University - Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Baylor Scoliosis Center

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Smith JS, Ben-Israel D, Kelly MP, Lafage V, Lafage R, Klineberg EO, Kim HJ, Line B, Protopsaltis TS, Passias P, Eastlack RK, Mundis GM, Riew KD, Kebaish K, Park P, Gupta MC, Gum JL, Daniels AH, Diebo BG, Hostin R, Scheer JK, Soroceanu A, Hamilton DK, Buell TJ, Lewis SJ, Lenke LG, Mullin JP, Schwab FJ, Burton D, Shaffrey CI, Ames CP, Bess S. The gap between surgeon goal and achieved sagittal alignment in adult cervical spine deformity surgery. J Neurosurg Spine. 2025 Jan 3;42(3):309-319. doi: 10.3171/2024.8.SPINE24703. Print 2025 Mar 1.

    PMID: 39752660DERIVED

MeSH Terms

Conditions

KyphosisScoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Justin Smith, MD, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 30, 2012

Study Start

January 9, 2013

Primary Completion

May 8, 2021

Study Completion

June 1, 2021

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

US(10)