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

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: Completed
• Conditions: Cancer; Osteoporosis; Compression Fracture of Vertebral Body
• Intervention / Treatment: Device: Balloon kyphoplasty

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 63 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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."	Baseline, 3 months after surgery
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).	Baseline, 3 months after surgery
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.	Baseline, 3 months after surgery
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.	Baseline, 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months
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).	Baseline, 30 days, 6 months, and 12 months
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.	Baseline, 30 days, 6 months, and 12 months
Quality of Life by EQ-5D Index Score		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		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;		Baseline, 30 days, 3 months, 6 months, and 12 months
Ambulatory Status		Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
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).	Baseline, 30 days, 3 months 6 months, and 12 months
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.	Baseline, 30 days, 3 months 6 months, and 12 months
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.	Baseline, pre-discharge, 3 months, and 12 months
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.	Baseline, pre-discharge, 3 months, and 12 months
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.	Baseline, pre-discharge, 3 months, and 12 months
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.	3 months and 12 months
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.	Pre-discharge, 30 days, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: vertebral body compression fracture
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis; Fractures, Compression
• Other Study ID Numbers: P12-03