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Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs | Clinical Trials | Clareo Health

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

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

NCT01871519•Medtronic Spinal and Biologics

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Identified as an appropriate candidate for BKP and should have made the choice to have the procedure.
•2. Must be Medicare Eligible (At least 65 years of age or otherwise eligible).
•3. Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer.
•4. Cancer patients should not have had a change in chemotherapy regimen within the last month, nor should they have a planned change within the next month from time of enrollment, with the exception of changes in dose.
•5. All VCFs to be treated must have clinical pain symptoms (pain on palpation/percussion over the fractured vertebral body) that correlate with radiographic findings as follows:
•1. Height change: An acute (≤ four month) change in VB height or morphology from a previous x-ray, CT or MRI, with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of one or more grades by the Genant criteria20, OR
•2. Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI, or target VB is positive on radionuclide bone scan.
•6. All VCFs to be treated must have an estimated fracture age of four months or less.
•7. Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty.
•8. Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management.
+5 more criteria

Exclusion Criteria

•1. Vertebral body morphology or fracture configuration contraindicative of balloon kyphoplasty.
•2. VCFs due to high-energy trauma.
•3. Asymptomatic VCFs or prophylactic treatment of non-fractured vertebral bodies.
•4. VCFs accompanied at the same site by primary tumors of the bone (e.g., osteosarcoma), solitary plasmacytoma or osteoblastic tumors.
•5. Platelet count of \<20,000/uL as measured at the time of hospital admission for the procedure.
•6. Back pain due to causes other than acute fracture.
•7. VCF with a clinically estimated (based on radiographic evidence as well as patient history) age of fracture \> four months.
•8. VCF accompanied by objective evidence of secondary radiculopathy or neurologic compromise.
•9. VCFs with the need for spinal surgery beyond balloon kyphoplasty.
•10. Spinal cord compression or canal compromise requiring decompression.
+8 more criteria

Locations (25)

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

Key Dates

Start Date

May 1, 2013

Primary Completion Date

December 1, 2015

Completion Date

May 1, 2016

Last Updated

March 29, 2017

Enrollment

354

ACTUAL participants

Conditions

Compression Fracture of Vertebral BodyOsteoporosisCancer

Interventions

Balloon kyphoplasty

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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