Trial record 5 of 7 for:    Open Studies | "Fractures, Compression"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medtronic Spinal and Biologics
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01871519
First received: June 4, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Compression Fracture of Vertebral Body
Osteoporosis
Cancer.
Device: Balloon kyphoplasty

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Change from baseline in back function by Oswestry Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in back pain by Numerical Rating Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life by SF-36v2 Physical Component Summary [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life by the EQ-5D [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: May 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Balloon Kyphoplasty
This group of patients will be treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Device: Balloon kyphoplasty
The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Other Name: BKP

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  9. Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale).
  10. Must have life expectancy of ≥ 12 months.
  11. Must declare availability for all study visits.
  12. Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.
  13. Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.

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.
  11. Significant clinical comorbidity that may either contra-indicate surgery or interfere with long-term data collection or follow-up.
  12. Pre-existing conditions contrary to balloon kyphoplasty such as:

    1. Allergy to any components (e.g., bone cement, contrast medium) of the balloon kyphoplasty device/procedure.
    2. Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection.
    3. Irreversible coagulopathy or bleeding disorder.
  13. Contraindications to both MRI and radionuclide bone scan.
  14. Concurrent participation in another clinical study.
  15. Pregnant or intending to become pregnant during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871519

Contacts
Contact: Clinical Department 1800-876-3133 ext 6068 msbkclinicalresearch@medtronic.com

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC Recruiting
Birmingham, Alabama, United States, 35235
Contact: Kim Jones    205-833-2228      
Principal Investigator: Bradly Goodman, MD         
University of Alabama at Birmingham, Division of Neurological Surgery Recruiting
Birmingham, Alabama, United States, 35294
Contact: Meredith Owens    205-318-7950      
Principal Investigator: Melissa R. Chambers, MD         
United States, California
Washington Radiologist Medical Group Recruiting
Fremont, California, United States, 94538
Contact: Russell Davis    510-745-6480      
Principal Investigator: Bruce H. Lin, MD         
Sutter Health Sacramento Sierra Region Recruiting
Sacramento, California, United States, 95816
Contact: Christina Dyer    916-454-6962      
Principal Investigator: Mark Davidian, MD         
Alta Orthopaedic Medical Group Recruiting
Santa Barbara, California, United States, 93101
Contact: Samantha Yim    805-963-9377      
Principal Investigator: Stuart Hutchinson, MD         
Torrance Memorial Medical Center Recruiting
Torrance, California, United States, 90505
Contact: Jaquelina Patti    310-257-5781      
Principal Investigator: George So, MD         
United States, Florida
Radiology Imaging Specialist of Lakeland Recruiting
Lakeland, Florida, United States, 33805
Contact: Robin Stewart    863-904-1877      
Principal Investigator: Venkat Tummala, MD         
The Back Center Recruiting
Melbourne, Florida, United States, 32901
Contact: Kimberly Sellati    321-541-1587      
Principal Investigator: Devin Datta, MD         
United States, Idaho
Physicians & Surgeons of Pocatello Recruiting
Blackfoot, Idaho, United States, 83221
Contact: Tamara Roush    208-782-2953      
Principal Investigator: David Shelley, MD         
United States, Illinois
Central Illinois Neuroscience Foundation Recruiting
Bloomington, Illinois, United States, 61701
Contact: Leslie Campbell    309-663-1522      
Principal Investigator: Ann R. Stroink, MD         
Adventist Health Partners Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Kathleen Mansell    708-245-8161      
Principal Investigator: Frank Facchini, MD         
Presence Saint Joseph Medical Center Recruiting
Joliet, Illinois, United States, 60435
Contact: Laura Paganessi    815-773-7031      
Principal Investigator: Joshua Tepper, MD         
Illinois Bone & Joint Recruiting
Morton Grove, Illinois, United States, 60053
Contact: Gabriela Twardowski    847-324-3925      
Principal Investigator: Thomas F. Gleason, MD         
United States, Indiana
Indiana Spine Group Recruiting
Carmel, Indiana, United States, 46032
Contact: Sheetal Vinayek    317-715-5897      
Principal Investigator: Kevin Macadaeg, MD         
United States, Michigan
Advanced Diagnostic Imaging, PC Recruiting
Saginaw, Michigan, United States, 48603
Contact: Robert Toevs    989-753-9000      
Principal Investigator: Sanjay Talati, MD         
United States, Mississippi
Premier Radiology Recruiting
Tupelo, Mississippi, United States, 38802
Contact: Dennis Rowland    662-620-7111      
Principal Investigator: Jeffrey Howard, MD         
United States, Nevada
Sierra Regional Spine Institute Recruiting
Reno, Nevada, United States, 89509
Contact: Gayle Stevens    775-448-9432      
Principal Investigator: James Rappaport, MD         
United States, Ohio
Consulting Orthopaedic Associates, Inc Recruiting
Sylvania, Ohio, United States, 43560
Contact: Nicole Cordrey    419-517-7500      
Principal Investigator: Thomas Andreshak, MD         
United States, Oklahoma
Clinical Investigations, LLC Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Jennifer Witherby    405-601-2325      
Principal Investigator: Douglas Beall, MD         
James R. Webb, P.C. Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Ashleigh Dugan    918-630-0660      
Principal Investigator: James R. Webb, MD         
United States, Oregon
NeuroSpine Institute, LLC Recruiting
Eugene, Oregon, United States, 97401
Contact: Shawn Potts    541-284-0530      
Principal Investigator: Gregory A. Moore, MD         
United States, Tennessee
Scoliosis & Spine Surgery Clinic of Memphis, PLLC Recruiting
Memphis, Tennessee, United States, 38119
Contact: Laura Dickey    901-767-9500      
Principal Investigator: Douglas Linville, MD         
Sponsors and Collaborators
Medtronic Spinal and Biologics
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01871519     History of Changes
Other Study ID Numbers: P12-03
Study First Received: June 4, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spinal and Biologics:
vertebral body compression fracture

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Fractures, Compression
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 08, 2014