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Active, not recruitingNCT00738439PONUpdated Mar 27, 2026

Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

An observational study in Spinal Deformity, sponsored by International Spine Study Group Foundation. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by International Spine Study Group Foundation · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,999
Ages
18 Years and older
Sex
All
01

Study summary

The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.

02

Conditions studied

  • Spinal Deformity

Browse trials for

Keywords

  • scoliosis
  • kyphosis
  • treatment outcomes
  • spinal deformity
03

In context

Scoliosis

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's enrollment of 1,999 is above the median of 84 across 256 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

International Spine Study Group Foundation is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,999 participants (actual)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Radiographic

    Coronal and Sagittal views of the spine

    Time frame: initial visit, 1 year, 2 years, 3-5 years

Secondary outcomes

  1. Clinical outcomes

    physical examination/pain scale

    Time frame: initial visit, 1 year, 2 years, 3-5 years

  2. Health related quality of life

    Oswestry, SRS22r, SF-36, LSDI, EQ5D3L, NDI DRAM (optional)

    Time frame: initial visit, 1 year, 2 years, 3-5 years

07

Study locations

9 sites
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2008, a primary completion of Dec 2026 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2008
First posted
Aug 20, 2008
Start
Oct 2008
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00738439
Lead sponsor
International Spine Study Group Foundation
Collaborators
NuVasive
Responsible party
Sponsor
First posted
Aug 20, 2008
Start date
Oct 2008
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Shay Bess, MD
principal investigator · Denver International Spine Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

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Other studies from this sponsor

International Spine Study Group Foundation

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