Spinal DeformityPONNCT00738439
Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
An observational study of Spinal Deformity, run by International Spine Study Group Foundation at 9 sites in United States.
Trial summary
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity
- How many people
- 1,999 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2008to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients greater than 18 years of age who meet inclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
- Age <18 yrs at time of surgery or initial consultation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins University
Baltimore, Maryland, 21287-0882
University of Virginia
Charlottesville, Virginia, 22908
Denver International Spine Center
Denver, Colorado, 80218
Doug Burton, MD
Kansas City, Kansas, 66160-7387
Scripps Clinic
La Jolla, California, 92037
NYU Hospital for Joint Diseases
New York, New York, 10010
Hospital for Special Surgery
New York, New York, 10021
University of California - Davis
Sacramento, California, 95817
University of California - San Francisco Medical Center
San Francisco, California, 94143
About this study
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.
- Conditions
- Spinal Deformity
- Keywords
- scoliosis, kyphosis, treatment outcomes, spinal deformity
- Medical subject headings
- Scoliosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Radiographic
Coronal and Sagittal views of the spine
Measured: initial visit, 1 year, 2 years, 3-5 years
Secondary outcomes (2)
Clinical outcomes
physical examination/pain scale
Measured: initial visit, 1 year, 2 years, 3-5 years
Health related quality of life
Oswestry, SRS22r, SF-36, LSDI, EQ5D3L, NDI DRAM (optional)
Measured: initial visit, 1 year, 2 years, 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Spine Study Group Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- NuVasive
- Responsible party
- Sponsor
- Investigators
- Shay Bess, MD, Principal investigator, Denver International Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738439
- Sponsor's protocol ID
- 1-08-1850
- Acronym
- PON
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2008
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Passias PG, Soroceanu A, Scheer J, Yang S, Boniello A, Smith JS, Protopsaltis T, Kim HJ, Schwab F, Gupta M, Klineberg E, Mundis G, Lafage R, Hart R, Shaffrey C, Lafage V, Ames C; International Spine Study Group. Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up. Spine J. 2015 Aug 1;15(8):1756-63. doi: 10.1016/j.spinee.2015.04.007. Epub 2015 Apr 8.
PubMed 25862507
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
- ClinicalTrials.gov ID
- NCT00738439
- Acronym / sponsor ID
- PON / 1-08-1850
- Conditions
- Spinal Deformity
- Keywords
- scoliosis, kyphosis, treatment outcomes, spinal deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,999 participants (actual)
- Lead sponsor
- International Spine Study Group FoundationUniversity, hospital or other
- Collaborators
- NuVasive
- Study start
- Oct 2008
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients greater than 18 years of age who meet inclusion criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
- Age <18 yrs at time of surgery or initial consultation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic
Time frame: initial visit, 1 year, 2 years, 3-5 years
Coronal and Sagittal views of the spine
2 secondary outcomes
Clinical outcomes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 25862507Passias PG, Soroceanu A, Scheer J, Yang S, Boniello A, Smith JS, Protopsaltis T, Kim HJ, Schwab F, Gupta M, Klineberg E, Mundis G, Lafage R, Hart R, Shaffrey C, Lafage V, Ames C; International Spine Study Group. Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up. Spine J. 2015 Aug 1;15(8):1756-63. doi: 10.1016/j.spinee.2015.04.007. Epub 2015 Apr 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shay Bess, MD principal investigator
Denver International Spine Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Deformity, run by International Spine Study Group Foundation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic (time frame: initial visit, 1 year, 2 years, 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.