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NCT01871519 · ClinicalTrials.gov registry record · NA

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

A NA study of Cancer and Osteoporosis, sponsored by Medtronic Spinal and Biologics.

Completed
Registry status
NA
Development phase
354
Enrollment target
20
Study locations

NCT01871519 is a NA study of Cancer and Osteoporosis that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 354 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT01871519, a NA study of Cancer and Osteoporosis, has completed, sponsored by Medtronic Spinal and Biologics.

COMPLETED
Registry status
NA
Development phase
354 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Cancer Osteoporosis Compression Fracture of Vertebral Body

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

26 total trials

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What the Registry Record Tells You About NCT01871519

The ClinicalTrials.gov registry entry for NCT01871519 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Medtronic Spinal and Biologics, which has 26 total studies on file at ClinicalTrials.gov.

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.

NCT01871519 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Alabama.

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.

What interventions are being tested in trial NCT01871519?

The interventions under investigation include: Balloon kyphoplasty (DEVICE).

Who is sponsoring clinical trial NCT01871519?

This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.