Clinical trial NCT01175278: Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
Official title: A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Myeloma
Keywords: vertebral
compression
fracture
VCF
kyphoplasty
spine
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Medtronics, Inc.
First posted: 2010-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Primary outcomes:
measure: Time to Vertebral Event
timeFrame: Average of 12 months
measure: Time to Pain Progression
timeFrame: Average of 12 months
Secondary outcomes:
measure: Rate of Vertebral Events
timeFrame: 12 months
measure: Rate of Hospitalization
timeFrame: 12 months
measure: Complications of Procedure
timeFrame: Average of 12 months
measure: Quality of Life Questionnaire Results
timeFrame: Average of 12 months
measure: Changes in Pulmonary Function
timeFrame: Average of 12 months
measure: Change in Kyphosis
timeFrame: Average of 12 months
measure: Prognostic Ability of Bone Biomarkers
timeFrame: Average of 12 months
Other outcomes:
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Frank Vrionis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: