Spots Global Cancer Trial Database for Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
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Trial Identification
Brief Title: Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
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
Study ID: NCT01871519
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States
University of Alabama at Birmingham, Division of Neurological Surgery, Birmingham, Alabama, United States
Washington Radiologist Medical Group, Fremont, California, United States
Sutter Health Sacramento Sierra Region, Sacramento, California, United States
Alta Orthopaedic Medical Group, Santa Barbara, California, United States
Torrance Memorial Medical Center, Torrance, California, United States
Radiology Imaging Specialist of Lakeland, Lakeland, Florida, United States
The Back Center, Melbourne, Florida, United States
Physicians & Surgeons of Pocatello, Blackfoot, Idaho, United States
St. Luke's Health System, Boise, Idaho, United States
Central Illinois Neuroscience Foundation, Bloomington, Illinois, United States
Adventist Health Partners, Hinsdale, Illinois, United States
Presence Saint Joseph Medical Center, Joliet, Illinois, United States
Illinois Bone & Joint, Morton Grove, Illinois, United States
Indiana Spine Group, Carmel, Indiana, United States
Advanced Diagnostic Imaging, PC, Saginaw, Michigan, United States
Beaumont Health System, Troy, Michigan, United States
Premier Radiology, Tupelo, Mississippi, United States
Sierra Regional Spine Institute, Reno, Nevada, United States
Consulting Orthopaedic Associates, Inc, Sylvania, Ohio, United States
Clinical Investigations, LLC, Edmond, Oklahoma, United States
James R. Webb, P.C., Tulsa, Oklahoma, United States
NeuroSpine Institute, LLC, Eugene, Oregon, United States
Scoliosis & Spine Surgery Clinic of Memphis, PLLC, Memphis, Tennessee, United States
The West Clinic, Memphis, Tennessee, United States
Contact Details
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