Status:
COMPLETED
Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Compression Fracture of Vertebral Body
Osteoporosis
Eligibility:
All Genders
65+ years
Phase:
NA
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 kyph...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT01871519
Start Date
May 1 2013
End Date
May 1 2016
Last Update
March 29 2017
Active Locations (25)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
University of Alabama at Birmingham, Division of Neurological Surgery
Birmingham, Alabama, United States, 35294
3
Washington Radiologist Medical Group
Fremont, California, United States, 94538
4
Sutter Health Sacramento Sierra Region
Sacramento, California, United States, 95816