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COMPLETED NA

Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs

NCT01871519 · View on ClinicalTrials.gov ↗

Study Summary

The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.

Interventions

  • DEVICE Balloon kyphoplasty

Study Locations (20)

California

  • Washington Radiologist Medical Group — Fremont
  • Sutter Health Sacramento Sierra Region — Sacramento
  • Alta Orthopaedic Medical Group — Santa Barbara
  • Torrance Memorial Medical Center — Torrance

Illinois

  • Central Illinois Neuroscience Foundation — Bloomington
  • Adventist Health Partners — Hinsdale
  • Presence Saint Joseph Medical Center — Joliet
  • Illinois Bone & Joint — Morton Grove

Alabama

  • Alabama Clinical Therapeutics, LLC — Birmingham
  • University of Alabama at Birmingham, Division of Neurological Surgery — Birmingham

Florida

  • Radiology Imaging Specialist of Lakeland — Lakeland
  • The Back Center — Melbourne

Idaho

  • Physicians & Surgeons of Pocatello — Blackfoot
  • St. Luke's Health System — Boise

Michigan

  • Advanced Diagnostic Imaging, PC — Saginaw
  • Beaumont Health System — Troy

Indiana

  • Indiana Spine Group — Carmel

Mississippi

  • Premier Radiology — Tupelo

Trial Details

FieldValue
Enrollment Target 354 participants
Start Date 2013-05
Est. Completion 2016-05
Phase NA

Sponsor

Medtronic Spinal and Biologics

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01871519

The ClinicalTrials.gov registry entry for NCT01871519 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 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Spinal and Biologics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which Balloon kyphoplasty 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: NCT01871519 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Alabama. 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 NCT01871519 about?

NCT01871519 is a clinical study titled "Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs". The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated w...

What is the current status of trial NCT01871519?

This trial is currently completed. It is a NA study. The enrollment target is 354 participants. The study started on 2013-05. Estimated completion is 2016-05.

What conditions does trial NCT01871519 study?

This clinical trial studies the following conditions: Cancer, Osteoporosis, Compression Fracture of Vertebral Body. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01871519?

The interventions under investigation include: Balloon kyphoplasty (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01871519?

This trial is sponsored by Medtronic Spinal and Biologics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01871519 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Idaho, Illinois. 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