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NCT02035280 · ClinicalTrials.gov registry record
Prospective Evaluation of Elderly Deformity Surgery
A clinical trial of Adult Spinal Deformity, sponsored by AO Foundation, AO Spine.
- Completed
- Registry status
- 233
- Enrollment target
- 13
- Study locations
NCT02035280: Completed study of Adult Spinal Deformity, sponsored by AO Foundation, AO Spine.
NCT02035280 is a study of Adult Spinal Deformity that has completed, run by AO Foundation, AO Spine. The registered enrollment target is 233 participants, below the 742-participant average among 3 other Adult Spinal Deformity trials with a reported enrollment target (69% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02035280, a study of Adult Spinal Deformity, has completed, sponsored by AO Foundation, AO Spine.
- COMPLETED
- Registry status
- 233 participants
- Enrollment target
- 13
- Study locations
Study Summary
As the population continues to age, the prevalence of spinal deformity surgery for older patients is increasing. Questions regarding the suitability of these patients to undergo large spinal procedures and whether the outcomes merit the risks involved are not well known.
Primary Outcome
The primary outcome is the absolute change in the SRS-22r total score between baseline and 24-months follow-up (FU) values in patients at age 60 or older treated with major spinal reconstruction. The SRS-22r is a patient-reported outcome instrument and has a range from 1 (worst) to 5 (best). It contains 22 questions covering five domains: function, pain, self-image, mental health (each with 5 items), and satisfaction with treatment (2 items) and each item is scored from 1 to 5.
Conditions Studied
Study Locations (13)
Other
- Queen Mary Hospital - Hong Kong
- Nanjing University Medical School - Nanjing
- Rigshospitalet - Copenhagen
- Hamamatsu University School of Medicine - Hamamatsu
- St. Maartens Kliniek - Nijmegen
- Hospital Vall d'Hebron - Barcelona
- Aciboden Maser Hospital - Istanbul
California
- UCSF Medical Center - San Francisco
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Washington University Orthopedics - St Louis
New York
- New York Presbyterian - Columbia University Medical Center - New York
Virginia
- University of Virginia - Charlottesville
Ontario
- Toronto Western Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2013-12 |
| Est. Completion | 2022-12 |
What the finished NCT02035280 record still lists
NCT02035280 is an observational study that tracks outcomes without assigning an intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, below the 742-participant average among 3 other Adult Spinal Deformity trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Adult Spinal Deformity appearing as the primary indexed condition, and to 0 interventions.
NCT02035280 lists 13 locations in 7 states (Other, California, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02035280 about?
NCT02035280 is a clinical study titled "Prospective Evaluation of Elderly Deformity Surgery". As the population continues to age, the prevalence of spinal deformity surgery for older patients is increasing. Questions regarding the suitability of these patients to undergo large spinal procedures and whether the outcomes merit the risks involved are not well known.
What is the current status of trial NCT02035280?
This trial is currently completed. The enrollment target is 233 participants. The study started on 2013-12. Estimated completion is 2022-12.
What conditions does trial NCT02035280 study?
This clinical trial studies the following conditions: Adult Spinal Deformity.
Who is sponsoring clinical trial NCT02035280?
This trial is sponsored by AO Foundation, AO Spine, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02035280 being conducted?
This trial has 13 study locations across California, Minnesota, Missouri, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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