Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures

NCT01175278 | Withdrawn DMC

• 2 other identifiers: MCC-15839Pro00000214
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Keywords

vertebral; compression; fracture; VCF; kyphoplasty; spine

Outcome Measures

Primary Outcomes (2)

• Time to Vertebral Event

  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)

  Average of 12 months

• Time to Pain Progression

  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

  Average of 12 months

Secondary Outcomes (7)

• Rate of Vertebral Events

  12 months

• Rate of Hospitalization

  12 months

• Complications of Procedure

  Average of 12 months

• Quality of Life Questionnaire Results

  Average of 12 months

• Changes in Pulmonary Function

  Average of 12 months

Study Arms (3)

Observation Arm

NO INTERVENTION

Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.

Balloon Kypholasty

EXPERIMENTAL

Procedure: Vertebral Augmentation with Balloon Kyphoplasty

Control Arm

ACTIVE COMPARATOR

Non-surgical Management Treatment Group

Other: Non-surgical Treatment

Interventions

Vertebral Augmentation with Balloon Kyphoplasty PROCEDURE

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.

Balloon Kypholasty

Non-surgical Treatment OTHER

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).

Control Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Medtronics, Inc.: collaborator

MeSH Terms

Conditions

Multiple Myeloma; Fractures, Bone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Wounds and Injuries

Study Officials

• Frank Vrionis, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 4, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 12, 2012

Record last verified: 2012-01