Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures - Full Text View

Purpose

The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.

Condition	Intervention
Multiple Myeloma	Procedure: Vertebral Augmentation with Balloon Kyphoplasty Other: Non-surgical Treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fractures Multiple Myeloma

U.S. FDA Resources

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:

Time to Vertebral Event [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)
Time to Pain Progression [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture

Secondary Outcome Measures:

Rate of Vertebral Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months
Rate of Hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months
Complications of Procedure [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Complications of vertebral augmentation
Quality of Life Questionnaire Results [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability
Changes in Pulmonary Function [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture
Change in Kyphosis [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant
Prognostic Ability of Bone Biomarkers [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Prognostic ability of bone biomarkers for the prediction of vertebral events

Enrollment:	0
Study Start Date:	July 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Observation Arm Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.
Experimental: Balloon Kypholasty	Procedure: Vertebral Augmentation with Balloon Kyphoplasty Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.
Active Comparator: Control Arm Non-surgical Management Treatment Group	Other: Non-surgical Treatment Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).

Detailed Description:

This is a prospective single center study designed to compare balloon kyphoplasty to non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body compression fractures in multiple myeloma patients. Because of the pilot nature and the small sample size of the study, patient randomization will NOT be stratified. Patients with mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization either balloon kyphoplasty or non surgical management. Randomization assignments will be generated by computer and investigator notified once the patient enrolled.

The observational arm will be compared to each of the other two arms; control and intervention arm using the same outcome variables and statistical methods.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with multiple myeloma (active or smoldering) with mild back pain (Visual Analog Scale [VAS]) ≤ 4 or no back pain (VAS=0) on a stable analgesic regimen) related to vertebral compression fractures (at least one and up to 8 index fractures from T3 to L5) as seen on magnetic resonancy imaging (MRI), computed axial tomography (CT) scan or plain radiographs.
No major planned spine surgery for at least 6 months following enrollment.
No evidence of epidural disease or cord compromise on magnetic resonance imaging.
Life expectancy greater than 6 months.
Adequate myeloma systemic control (no evidence of active progressive disease). No planned change in chemotherapy regimen for 1 month prior and for at least 1 month following enrollment. Change in dose(s) permitted.
Adequate hematologic parameters (platelet count≥50,000/μL, and absolute neutrophil count ≥1,000). Platelet transfusions are permitted to increase platelet counts perioperatively.
Age greater than 21 years and able to understand and sign the informed consent document.

Exclusion Criteria:

Patients with significant comorbidities (aside from the index fracture or cancer) which would result in an unacceptable surgical risk or patients with contraindications to general or local anesthesia.
Patients with other primary tumors including primary bone tumors or solitary plasmacytoma at site of the index VCF.
VCF morphology deemed unsuitable for balloon kyphoplasty (vertebra planum).
Additional non-kyphoplasty surgical treatment is required for the index fracture.
Patients with uncontrolled pain related to the VCF (VAS>4, or increasing opioid requirements), or with epidural disease on magnetic resonance imaging. Spinal cord compression , canal compromise and /or spinal instability requiring decompression.
Patients with a bleeding disorder which cannot be adequately managed perioperatively.
Patients with pain unrelated to the VCF according to the investigators.
Patients with estimated survival less than 6 months.
Known allergy to bone cement or all contrast media used in the treatment of study participants.
MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175278

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Medtronics, Inc.

Investigators

Principal Investigator:

Frank Vrionis, M.D.

H. Lee Moffitt Cancer Center and Research Institute

More Information

No publications provided

Responsible Party:	H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:	NCT01175278 History of Changes
Other Study ID Numbers:	MCC-15839, Pro00000214
Study First Received:	August 3, 2010
Last Updated:	January 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

vertebral
compression
fracture

VCF
kyphoplasty
spine

Additional relevant MeSH terms:

Fractures, Bone
Multiple Myeloma
Neoplasms, Plasma Cell
Fractures, Compression
Wounds and Injuries
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases

Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013