Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
Public ClinicalTrials.gov record NCT01871519. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01871519
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 354 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2013 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- May 2016 (Actual)
- Last update posted
- Mar 29, 2017
2013 – 2016
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| University of Alabama at Birmingham, Division of Neurological Surgery | Birmingham | Alabama | 35294 | — |
| Washington Radiologist Medical Group | Fremont | California | 94538 | — |
| Sutter Health Sacramento Sierra Region | Sacramento | California | 95816 | — |
| Alta Orthopaedic Medical Group | Santa Barbara | California | 93101 | — |
| Torrance Memorial Medical Center | Torrance | California | 90505 | — |
| Radiology Imaging Specialist of Lakeland | Lakeland | Florida | 33805 | — |
| The Back Center | Melbourne | Florida | 32901 | — |
| Physicians & Surgeons of Pocatello | Blackfoot | Idaho | 83221 | — |
| St. Luke's Health System | Boise | Idaho | 83712 | — |
| Central Illinois Neuroscience Foundation | Bloomington | Illinois | 61701 | — |
| Adventist Health Partners | Hinsdale | Illinois | 60521 | — |
| Presence Saint Joseph Medical Center | Joliet | Illinois | 60435 | — |
| Illinois Bone & Joint | Morton Grove | Illinois | 60053 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| Advanced Diagnostic Imaging, PC | Saginaw | Michigan | 48603 | — |
| Beaumont Health System | Troy | Michigan | 48085 | — |
| Premier Radiology | Tupelo | Mississippi | 38802 | — |
| Sierra Regional Spine Institute | Reno | Nevada | 89509 | — |
| Consulting Orthopaedic Associates, Inc | Sylvania | Ohio | 43560 | — |
| Clinical Investigations, LLC | Edmond | Oklahoma | 73013 | — |
| James R. Webb, P.C. | Tulsa | Oklahoma | 74133 | — |
| NeuroSpine Institute, LLC | Eugene | Oregon | 97401 | — |
| Scoliosis & Spine Surgery Clinic of Memphis, PLLC | Memphis | Tennessee | 38119 | — |
| The West Clinic | Memphis | Tennessee | 38120 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01871519, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2017 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01871519 live on ClinicalTrials.gov.