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

NCT ID: NCT01871519

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Compression Fracture of Vertebral Body; Osteoporosis; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Balloon kyphoplasty

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

BKP

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

University of Alabama at Birmingham, Division of Neurological Surgery

Birmingham, Alabama, United States

Washington Radiologist Medical Group

Fremont, California, United States

Sutter Health Sacramento Sierra Region

Sacramento, California, United States

Alta Orthopaedic Medical Group

Santa Barbara, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

Radiology Imaging Specialist of Lakeland

Lakeland, Florida, United States

The Back Center

Melbourne, Florida, United States

Physicians & Surgeons of Pocatello

Blackfoot, Idaho, United States

St. Luke's Health System

Boise, Idaho, United States

Central Illinois Neuroscience Foundation

Bloomington, Illinois, United States

Adventist Health Partners

Hinsdale, Illinois, United States

Presence Saint Joseph Medical Center

Joliet, Illinois, United States

Illinois Bone & Joint

Morton Grove, Illinois, United States

Indiana Spine Group

Carmel, Indiana, United States

Advanced Diagnostic Imaging, PC

Saginaw, Michigan, United States

Beaumont Health System

Troy, Michigan, United States

Premier Radiology

Tupelo, Mississippi, United States

Sierra Regional Spine Institute

Reno, Nevada, United States

Consulting Orthopaedic Associates, Inc

Sylvania, Ohio, United States

Clinical Investigations, LLC

Edmond, Oklahoma, United States

James R. Webb, P.C.

Tulsa, Oklahoma, United States

NeuroSpine Institute, LLC

Eugene, Oregon, United States

Scoliosis & Spine Surgery Clinic of Memphis, PLLC

Memphis, Tennessee, United States

The West Clinic

Memphis, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29547939 (View on PubMed)

Other Identifiers

P12-03

Identifier Type: -

Identifier Source: org_study_id