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COMPLETED NA

Min Implants Max Outcomes Clinical Trial

NCT01792609 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2013-04-18
Est. Completion 2019-06-01
Phase NA

Sponsor

University of Minnesota

919 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01792609

The ClinicalTrials.gov registry entry for NCT01792609 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01792609 reports 14 study locations spanning 13 distinct geographic areas — top geographies include Minnesota, Colorado, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01792609?

The interventions under investigation include: Maximum Number of Screws (PROCEDURE), Minimum Number of Screws (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01792609?

This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial