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Compression Fracture of Vertebral BodyEVOLVENCT01871519

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

A study testing Balloon kyphoplasty in people with Compression Fracture of Vertebral Body and Osteoporosis, run by Medtronic Spinal and Biologics at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Balloon kyphoplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
25 sitesUnited States
Study dates
May 2013to May 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Identified as an appropriate candidate for BKP and should have made the choice to have the procedure.
  • Must be Medicare Eligible (At least 65 years of age or otherwise eligible).
  • Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer.
  • 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.
  • 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:
  • 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
Show all 15Show fewer
  • Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI, or target VB is positive on radionuclide bone scan.
  • All VCFs to be treated must have an estimated fracture age of four months or less.
  • Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty.
  • Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management.
  • Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale).
  • Must have life expectancy of ≥ 12 months.
  • Must declare availability for all study visits.
  • Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.
  • Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.

Who cannot join

  • Vertebral body morphology or fracture configuration contraindicative of balloon kyphoplasty.
  • VCFs due to high-energy trauma.
  • Asymptomatic VCFs or prophylactic treatment of non-fractured vertebral bodies.
  • VCFs accompanied at the same site by primary tumors of the bone (e.g., osteosarcoma), solitary plasmacytoma or osteoblastic tumors.
  • Platelet count of <20,000/uL as measured at the time of hospital admission for the procedure.
  • Back pain due to causes other than acute fracture.
Show all 18Show fewer
  • VCF with a clinically estimated (based on radiographic evidence as well as patient history) age of fracture > four months.
  • VCF accompanied by objective evidence of secondary radiculopathy or neurologic compromise.
  • VCFs with the need for spinal surgery beyond balloon kyphoplasty.
  • Spinal cord compression or canal compromise requiring decompression.
  • Significant clinical comorbidity that may either contra-indicate surgery or interfere with long-term data collection or follow-up.
  • Pre-existing conditions contrary to balloon kyphoplasty such as:
  • Allergy to any components (e.g., bone cement, contrast medium) of the balloon kyphoplasty device/procedure.
  • Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection.
  • Irreversible coagulopathy or bleeding disorder.
  • Contraindications to both MRI and radionuclide bone scan.
  • Concurrent participation in another clinical study.
  • Pregnant or intending to become pregnant during the course of the study.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • University of Alabama at Birmingham, Division of Neurological Surgery

    Birmingham, Alabama, 35294

  • Physicians & Surgeons of Pocatello

    Blackfoot, Idaho, 83221

  • Central Illinois Neuroscience Foundation

    Bloomington, Illinois, 61701

  • St. Luke's Health System

    Boise, Idaho, 83712

  • Indiana Spine Group

    Carmel, Indiana, 46032

  • Clinical Investigations, LLC

    Edmond, Oklahoma, 73013

  • NeuroSpine Institute, LLC

    Eugene, Oregon, 97401

  • Washington Radiologist Medical Group

    Fremont, California, 94538

  • Adventist Health Partners

    Hinsdale, Illinois, 60521

  • Presence Saint Joseph Medical Center

    Joliet, Illinois, 60435

  • Radiology Imaging Specialist of Lakeland

    Lakeland, Florida, 33805

  • The Back Center

    Melbourne, Florida, 32901

  • Scoliosis & Spine Surgery Clinic of Memphis, PLLC

    Memphis, Tennessee, 38119

  • The West Clinic

    Memphis, Tennessee, 38120

  • Illinois Bone & Joint

    Morton Grove, Illinois, 60053

  • Sierra Regional Spine Institute

    Reno, Nevada, 89509

  • Sutter Health Sacramento Sierra Region

    Sacramento, California, 95816

  • Advanced Diagnostic Imaging, PC

    Saginaw, Michigan, 48603

  • Alta Orthopaedic Medical Group

    Santa Barbara, California, 93101

  • Consulting Orthopaedic Associates, Inc

    Sylvania, Ohio, 43560

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Beaumont Health System

    Troy, Michigan, 48085

  • James R. Webb, P.C.

    Tulsa, Oklahoma, 74133

  • Premier Radiology

    Tupelo, Mississippi, 38802

Other trials in United States

About this study

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

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.

Being tested
Balloon kyphoplasty
Keywords
vertebral body compression fracture
Medical subject headings
Osteoporosis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balloon kyphoplastyDevice

    Also called BKP

    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.

Study groups in NCT01871519
Study groupRoleWhat they receive
Balloon KyphoplastyOtherThis group of patients will be treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Receives: Device: Balloon kyphoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Back Pain Change From Baseline at 3 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."

    Measured: Baseline, 3 months after surgery

  2. Back Function Change From Baseline by Oswestry Disability Index at 3 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).

    Measured: Baseline, 3 months after surgery

  3. SF-36v2 Physical Component Summary Change From Baseline at 3 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.

    Measured: Baseline, 3 months after surgery

  4. Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months

    EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.

    Measured: Baseline, 3 months after surgery

Secondary outcomes (14)

  1. Back Pain

    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."

    Measured: Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months

  2. Back Function (ODI)

    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).

    Measured: Baseline, 30 days, 6 months, and 12 months

  3. Quality of Life by SF-36v2 PCS

    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.

    Measured: Baseline, 30 days, 6 months, and 12 months

  4. Quality of Life by EQ-5D Index Score

    Measured: Baseline, 30 days, 6 months, and 12 months

  5. Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks

    Measured: Baseline, 30 days, 3 months, 6 months, and 12 months

  6. The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;

    Measured: Baseline, 30 days, 3 months, 6 months, and 12 months

  7. Ambulatory Status

    Measured: Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months

  8. Barthel Index (Only for Subjects With Osteoporosis)

    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).

    Measured: Baseline, 30 days, 3 months 6 months, and 12 months

  9. Karnofsky Performance Scale

    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.

    Measured: Baseline, 30 days, 3 months 6 months, and 12 months

  10. Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)

    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.

    Measured: Baseline, pre-discharge, 3 months, and 12 months

  11. Vertebral Body Angle

    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.

    Measured: Baseline, pre-discharge, 3 months, and 12 months

  12. Local Cobb Angle

    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.

    Measured: Baseline, pre-discharge, 3 months, and 12 months

  13. Subsequent Radiographic Fractures

    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.

    Measured: 3 months and 12 months

  14. Neurological Success Rate

    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.

    Measured: Pre-discharge, 30 days, 3 months, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871519
Sponsor's protocol ID
P12-03
Acronym
EVOLVE
Status last verified
Feb 2017
First submitted
4 Jun 2013
Last updated
29 Mar 2017
Data monitoring committee
No

Publications

  • Beall DP, Chambers MR, Thomas S, Amburgy J, Webb JR Jr, Goodman BS, Datta DK, Easton RW, Linville D 2nd, Talati S, Tillman JB. 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 EVOLVE Trial. Neurosurgery. 2019 Jan 1;84(1):169-178. doi: 10.1093/neuros/nyy017.

    PubMed 29547939

Questions about this trial

What is this clinical trial studying?

A study testing Balloon kyphoplasty in people with Compression Fracture of Vertebral Body and Osteoporosis, run by Medtronic Spinal and Biologics at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Back Pain Change From Baseline at 3 Months (time frame: Baseline, 3 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871519, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

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