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

February 28, 2017 updated by: Medtronic Spinal and Biologics

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham, Division of Neurological Surgery
    • California
      • Fremont, California, United States, 94538
        • Washington Radiologist Medical Group
      • Sacramento, California, United States, 95816
        • Sutter Health Sacramento Sierra Region
      • Santa Barbara, California, United States, 93101
        • Alta Orthopaedic Medical Group
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Florida
      • Lakeland, Florida, United States, 33805
        • Radiology Imaging Specialist of Lakeland
      • Melbourne, Florida, United States, 32901
        • The BACK Center
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Physicians & Surgeons of Pocatello
      • Boise, Idaho, United States, 83712
        • St. Luke's Health System
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Central Illinois Neuroscience Foundation
      • Hinsdale, Illinois, United States, 60521
        • Adventist Health Partners
      • Joliet, Illinois, United States, 60435
        • Presence Saint Joseph Medical Center
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone & Joint
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana Spine Group
    • Michigan
      • Saginaw, Michigan, United States, 48603
        • Advanced Diagnostic Imaging, PC
      • Troy, Michigan, United States, 48085
        • Beaumont Health System
    • Mississippi
      • Tupelo, Mississippi, United States, 38802
        • Premier Radiology
    • Nevada
      • Reno, Nevada, United States, 89509
        • Sierra Regional Spine Institute
    • Ohio
      • Sylvania, Ohio, United States, 43560
        • Consulting Orthopaedic Associates, Inc
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Clinical Investigations, LLC
      • Tulsa, Oklahoma, United States, 74133
        • James R. Webb, P.C.
    • Oregon
      • Eugene, Oregon, United States, 97401
        • NeuroSpine Institute, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
      • Memphis, Tennessee, United States, 38119
        • Scoliosis & Spine Surgery Clinic of Memphis, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • BKP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Back Pain Change From Baseline at 3 Months
Time Frame: Baseline, 3 months after surgery
Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Baseline, 3 months after surgery
Back Function Change From Baseline by Oswestry Disability Index at 3 Months
Time Frame: Baseline, 3 months after surgery
ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Baseline, 3 months after surgery
SF-36v2 Physical Component Summary Change From Baseline at 3 Months
Time Frame: Baseline, 3 months after surgery
Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Baseline, 3 months after surgery
Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months
Time Frame: Baseline, 3 months after surgery
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Baseline, 3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Back Pain
Time Frame: Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months
Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months
Back Function (ODI)
Time Frame: Baseline, 30 days, 6 months, and 12 months
ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Baseline, 30 days, 6 months, and 12 months
Quality of Life by SF-36v2 PCS
Time Frame: Baseline, 30 days, 6 months, and 12 months
Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Baseline, 30 days, 6 months, and 12 months
Quality of Life by EQ-5D Index Score
Time Frame: Baseline, 30 days, 6 months, and 12 months
Baseline, 30 days, 6 months, and 12 months
Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
Time Frame: Baseline, 30 days, 3 months, 6 months, and 12 months
Baseline, 30 days, 3 months, 6 months, and 12 months
The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;
Time Frame: Baseline, 30 days, 3 months, 6 months, and 12 months
Baseline, 30 days, 3 months, 6 months, and 12 months
Ambulatory Status
Time Frame: Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
Barthel Index (Only for Subjects With Osteoporosis)
Time Frame: Baseline, 30 days, 3 months 6 months, and 12 months
For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).
Baseline, 30 days, 3 months 6 months, and 12 months
Karnofsky Performance Scale
Time Frame: Baseline, 30 days, 3 months 6 months, and 12 months
For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.
Baseline, 30 days, 3 months 6 months, and 12 months
Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)
Time Frame: Baseline, pre-discharge, 3 months, and 12 months
AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.
Baseline, pre-discharge, 3 months, and 12 months
Vertebral Body Angle
Time Frame: Baseline, pre-discharge, 3 months, and 12 months
The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.
Baseline, pre-discharge, 3 months, and 12 months
Local Cobb Angle
Time Frame: Baseline, pre-discharge, 3 months, and 12 months
The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.
Baseline, pre-discharge, 3 months, and 12 months
Subsequent Radiographic Fractures
Time Frame: 3 months and 12 months
A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.
3 months and 12 months
Neurological Success Rate
Time Frame: Pre-discharge, 30 days, 3 months, 6 months, and 12 months
Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.
Pre-discharge, 30 days, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Spinal and Biologics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P12-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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