Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry (PON)

March 23, 2026 updated by: International Spine Study Group Foundation
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

1999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Sacramento, California, United States, 95817
        • University of California - Davis
      • San Francisco, California, United States, 94143
        • University of California - San Francisco Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Denver International Spine Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7387
        • Doug Burton, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287-0882
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10010
        • NYU Hospital for Joint Diseases
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients greater than 18 years of age who meet inclusion criteria.

Description

Inclusion Criteria:

  • Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees
  • Sagittal Vertical Axis (SVA) > 5cm
  • Pelvic Tilt > 25 degrees
  • Thoracic kyphosis > 60 degrees
  • Age 18 or greater at the time of enrollment.

Exclusion Criteria:

  • Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
  • Age <18 yrs at time of surgery or initial consultation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Operative
Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees requiring surgery.
Nonoperative
Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees not requiring surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic
Time Frame: initial visit, 1 year, 2 years, 3-5 years
Coronal and Sagittal views of the spine
initial visit, 1 year, 2 years, 3-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: initial visit, 1 year, 2 years, 3-5 years
physical examination/pain scale
initial visit, 1 year, 2 years, 3-5 years
Health related quality of life
Time Frame: initial visit, 1 year, 2 years, 3-5 years
Oswestry, SRS22r, SF-36, LSDI, EQ5D3L, NDI DRAM (optional)
initial visit, 1 year, 2 years, 3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Spine Study Group Foundation

Collaborators

NuVasive

Investigators

  • Principal Investigator: Shay Bess, MD, Denver International Spine Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimated)

August 20, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-08-1850

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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