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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01871519
First received: June 4, 2013
Last updated: February 28, 2017
Last verified: February 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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:
  • 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."

  • 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).

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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."

  • 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).

  • 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.

  • Quality of Life by EQ-5D Index Score [ Time Frame: 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 ]
  • 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 ]
  • Ambulatory Status [ Time Frame: 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 354
Study Start Date: May 2013
Study Completion Date: May 2016
Primary Completion Date: December 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Spinal and Biologics
  More Information

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
Results First Received: December 14, 2016
Last Updated: February 28, 2017

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 21, 2017