Clinical trial NCT01871519: Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compression Fracture of Vertebral Body
Osteoporosis
Cancer
Keywords: vertebral body compression fracture
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 354
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility 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.

Primary outcomes:
measure: Back Pain Change From Baseline at 3 Months
timeFrame: Baseline, 3 months after surgery
measure: Back Function Change From Baseline by Oswestry Disability Index at 3 Months
timeFrame: Baseline, 3 months after surgery
measure: SF-36v2 Physical Component Summary Change From Baseline at 3 Months
timeFrame: Baseline, 3 months after surgery
measure: Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months
timeFrame: Baseline, 3 months after surgery
Secondary outcomes:
measure: Back Pain
timeFrame: Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months
measure: Back Function (ODI)
timeFrame: Baseline, 30 days, 6 months, and 12 months
measure: Quality of Life by SF-36v2 PCS
timeFrame: Baseline, 30 days, 6 months, and 12 months
measure: Quality of Life by EQ-5D Index Score
timeFrame: Baseline, 30 days, 6 months, and 12 months
measure: Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
timeFrame: Baseline, 30 days, 3 months, 6 months, and 12 months
measure: The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;
timeFrame: Baseline, 30 days, 3 months, 6 months, and 12 months
measure: Ambulatory Status
timeFrame: Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
measure: Barthel Index (Only for Subjects With Osteoporosis)
timeFrame: Baseline, 30 days, 3 months 6 months, and 12 months
measure: Karnofsky Performance Scale
timeFrame: Baseline, 30 days, 3 months 6 months, and 12 months
measure: Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)
timeFrame: Baseline, pre-discharge, 3 months, and 12 months
measure: Vertebral Body Angle
timeFrame: Baseline, pre-discharge, 3 months, and 12 months
measure: Local Cobb Angle
timeFrame: Baseline, pre-discharge, 3 months, and 12 months
measure: Subsequent Radiographic Fractures
timeFrame: 3 months and 12 months
measure: Neurological Success Rate
timeFrame: Pre-discharge, 30 days, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Division of Neurological Surgery
state: Alabama
city: Fremont
country: United States
facility: Washington Radiologist Medical Group
state: California
city: Sacramento
country: United States
facility: Sutter Health Sacramento Sierra Region
state: California
city: Santa Barbara
country: United States
facility: Alta Orthopaedic Medical Group
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Lakeland
country: United States
facility: Radiology Imaging Specialist of Lakeland
state: Florida
city: Melbourne
country: United States
facility: The Back Center
state: Florida
city: Blackfoot
country: United States
facility: Physicians & Surgeons of Pocatello
state: Idaho
city: Boise
country: United States
facility: St. Luke's Health System
state: Idaho
city: Bloomington
country: United States
facility: Central Illinois Neuroscience Foundation
state: Illinois
city: Hinsdale
country: United States
facility: Adventist Health Partners
state: Illinois
city: Joliet
country: United States
facility: Presence Saint Joseph Medical Center
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone & Joint
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Saginaw
country: United States
facility: Advanced Diagnostic Imaging, PC
state: Michigan
city: Troy
country: United States
facility: Beaumont Health System
state: Michigan
city: Tupelo
country: United States
facility: Premier Radiology
state: Mississippi
city: Reno
country: United States
facility: Sierra Regional Spine Institute
state: Nevada
city: Sylvania
country: United States
facility: Consulting Orthopaedic Associates, Inc
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: James R. Webb, P.C.
state: Oklahoma
city: Eugene
country: United States
facility: NeuroSpine Institute, LLC
state: Oregon
city: Memphis
country: United States
facility: Scoliosis & Spine Surgery Clinic of Memphis, PLLC
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
References:
citation: 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.