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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01871519
Other study ID # P12-03
Secondary ID
Status Completed
Phase N/A
First received June 4, 2013
Last updated November 2, 2016
Start date May 2013
Est. completion date May 2016

Study information

Verified date May 2016
Source Medtronic Spinal and Biologics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 354
Est. completion date May 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States University of Alabama at Birmingham, Division of Neurological Surgery Birmingham Alabama
United States Physicians & Surgeons of Pocatello Blackfoot Idaho
United States Central Illinois Neuroscience Foundation Bloomington Illinois
United States St. Luke's Health System Boise Idaho
United States Indiana Spine Group Carmel Indiana
United States Clinical Investigations, LLC Edmond Oklahoma
United States NeuroSpine Institute, LLC Eugene Oregon
United States Washington Radiologist Medical Group Fremont California
United States Adventist Health Partners Hinsdale Illinois
United States Presence Saint Joseph Medical Center Joliet Illinois
United States Radiology Imaging Specialist of Lakeland Lakeland Florida
United States The Back Center Melbourne Florida
United States Scoliosis & Spine Surgery Clinic of Memphis, PLLC Memphis Tennessee
United States The West Clinic Memphis Tennessee
United States Illinois Bone & Joint Morton Grove Illinois
United States Sierra Regional Spine Institute Reno Nevada
United States Sutter Health Sacramento Sierra Region Sacramento California
United States Advanced Diagnostic Imaging, PC Saginaw Michigan
United States Alta Orthopaedic Medical Group Santa Barbara California
United States Consulting Orthopaedic Associates, Inc Sylvania Ohio
United States Torrance Memorial Medical Center Torrance California
United States Beaumont Health System Troy Michigan
United States James R. Webb, P.C. Tulsa Oklahoma
United States Premier Radiology Tupelo Mississippi

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in back function by Oswestry Disability Index 3 months No
Primary Change from baseline in back pain by Numerical Rating Scale 3 months No
Primary Change from baseline in quality of life by SF-36v2 Physical Component Summary 3 months No
Primary Change from baseline in quality of life by the EQ-5D 3 months No
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