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

NCT01871519 | Completed Results

• 1 other identifier: P12-03
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 25

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

Keywords

vertebral body compression fracture

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Back Pain

  Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months

• Back Function (ODI)

  Baseline, 30 days, 6 months, and 12 months

• Quality of Life by SF-36v2 PCS

  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

Study Arms (1)

Balloon Kyphoplasty

OTHER

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

Interventions

Balloon kyphoplasty 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.

Also known as: BKP

Balloon Kyphoplasty

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (25)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

University of Alabama at Birmingham, Division of Neurological Surgery

Birmingham, Alabama, 35294, United States

Location

Washington Radiologist Medical Group

Fremont, California, 94538, United States

Location

Sutter Health Sacramento Sierra Region

Sacramento, California, 95816, United States

Location

Alta Orthopaedic Medical Group

Santa Barbara, California, 93101, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Radiology Imaging Specialist of Lakeland

Lakeland, Florida, 33805, United States

Location

The Back Center

Melbourne, Florida, 32901, United States

Location

Physicians & Surgeons of Pocatello

Blackfoot, Idaho, 83221, United States

Location

St. Luke's Health System

Boise, Idaho, 83712, United States

Location

Central Illinois Neuroscience Foundation

Bloomington, Illinois, 61701, United States

Location

Adventist Health Partners

Hinsdale, Illinois, 60521, United States

Location

Presence Saint Joseph Medical Center

Joliet, Illinois, 60435, United States

Location

Illinois Bone & Joint

Morton Grove, Illinois, 60053, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Advanced Diagnostic Imaging, PC

Saginaw, Michigan, 48603, United States

Location

Beaumont Health System

Troy, Michigan, 48085, United States

Location

Premier Radiology

Tupelo, Mississippi, 38802, United States

Location

Sierra Regional Spine Institute

Reno, Nevada, 89509, United States

Location

Consulting Orthopaedic Associates, Inc

Sylvania, Ohio, 43560, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

Location

James R. Webb, P.C.

Tulsa, Oklahoma, 74133, United States

Location

NeuroSpine Institute, LLC

Eugene, Oregon, 97401, United States

Location

Scoliosis & Spine Surgery Clinic of Memphis, PLLC

Memphis, Tennessee, 38119, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Related Publications (1)

• 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.

  PMID: 29547939 DERIVED

MeSH Terms

Conditions

Osteoporosis; Neoplasms

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal

msbkclinicalresearch@medtronic.com

1800-876-3133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 29, 2017
• Results First Posted: February 7, 2017

Record last verified: 2017-02

Locations

US (25)