Clinical trial · Interventional
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-surgical Treatment | Other | — | UNRESOLVED |
| Vertebral Augmentation with Balloon Kyphoplasty | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Observation Arm
- description
- Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.
- type
- EXPERIMENTAL
- label
- Balloon Kypholasty
- interventionNames
- Procedure: Vertebral Augmentation with Balloon Kyphoplasty
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Non-surgical Management Treatment Group
- interventionNames
- Other: Non-surgical Treatment
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available