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NCT01792609 · ClinicalTrials.gov registry record · NA
Min Implants Max Outcomes Clinical Trial
A NA study of Scoliosis and Adolescent Idiopathic Scoliosis, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 14
- Study locations
NCT01792609: Completed NA study of Scoliosis and Adolescent Idiopathic Scoliosis, sponsored by University of Minnesota.
NCT01792609 is a NA study of Scoliosis and Adolescent Idiopathic Scoliosis that has completed, run by University of Minnesota. The registered enrollment target is 200 participants, below the 1,205-participant average among 17 other Scoliosis trials with a reported enrollment target (83% lower). The trial reports 14 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01792609, a NA study of Scoliosis and Adolescent Idiopathic Scoliosis, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 14
- Study locations
Study Summary
Objectives Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial. Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety of low vs. high implant density instrumentation for spine deformity surgery in AIS patients with Lenke IA curve patterns. Interventions and Duration Intervention: low-implant density group or high-implant density group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174 subjects with 87 in each group.
Primary Outcome
Radiographic, surgical, and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with 3D analysis capability, either with a calibration belt using standard radiograph techniques or with an EOS imaging system. This will allow for additional detailed correction measures, such as change in spinal rotation (orientation of the planes of maximum curvature) and detailed coronal, sagittal and transverse plane measures. Bending films wi
Conditions Studied
Interventions
- PROCEDURE Maximum Number of Screws
- PROCEDURE Minimum Number of Screws
Study Locations (14)
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours/ Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's Research Institute - Washington D.C.
Florida
- University of Florida - Gainesville
Georgia
- Emory University - Atlanta
Iowa
- University of Iowa - Iowa City
Kentucky
- Norton Leatherman Spine Center - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-04-18 |
| Est. Completion | 2019-06-01 |
| Phase | NA |
What the finished NCT01792609 record still lists
NCT01792609 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,205-participant average among 17 other Scoliosis trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Scoliosis appearing as the primary indexed condition, and to 2 interventions - of which Maximum Number of Screws is the first listed.
NCT01792609 lists 14 locations in 13 states (Minnesota, Colorado, Delaware).
Frequently Asked Questions
What is clinical trial NCT01792609 about?
NCT01792609 is a clinical study titled "Min Implants Max Outcomes Clinical Trial". Objectives Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial. Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and...
What is the current status of trial NCT01792609?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2013-04-18. Estimated completion is 2019-06-01.
What conditions does trial NCT01792609 study?
This clinical trial studies the following conditions: Scoliosis, Adolescent Idiopathic Scoliosis.
What interventions are being tested in trial NCT01792609?
The interventions under investigation include: Maximum Number of Screws (PROCEDURE), Minimum Number of Screws (PROCEDURE).
Who is sponsoring clinical trial NCT01792609?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01792609 being conducted?
This trial has 14 study locations across Colorado, Delaware, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01792609's enrollment target sits among peer trials
200 10th of 17 higher than 8 of 17 other Scoliosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Scoliosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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