Clinical trial · Interventional
Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.
Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): the data collected are enough to obtain a qualitative analysis.
Summary
Brief summary (as posted)
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications. This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure. Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient. The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.
Conditions
Conditions (3)
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 |
| Osteolytic Metastases | — | UNRESOLVED | — |
| Vertebral Fracture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| balloon kyphoplasty | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- balloon Kyphoplasty
- interventionNames
- Device: balloon kyphoplasty
Primary outcomes (1)
- measure
- Percentage of patients having a residual pain of ≤ 35mm on a VAS scale or a 50 % decrease in daily morphine dose at day 15 after Balloon Kyphoplasty compared to day 0 (day of procedure).
- timeFrame
- day 15
Secondary outcomes (12)
- measure
- 1° Clinical Outcomes:· Pain evaluation using a visual analogic scale
- timeFrame
- D-8-D-1, D2 to D5, d15, D90, D180; D360
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, 18 years or older 2. 1 to 3 vertebral compression fracture(s), between T5-L5, responding to the following criteria: * at least 15% loss of vertebral body height (anterior, median or posterior); * malignant origin (bone metastases, multiple myeloma, hemopathy) assessed by imaging, including an MRI and a CT-SCAN of less than 4 weeks. * Pain or painful deterioration less than 3 months old, related to one or more vertebral fractures with a VAS higher than 50/100 mm when changing position, or higher than 40/100 mm if associated with morphine ≥ 30 mg/day ; 3. The pain related to the fractured vertebrae is the more prevalent 4. More than 3 months life expectancy. 5. Blood Platelets rate more than or equal to 50 000/mm3 within the week before balloon kyphoplasty procedure (after a correct blood transfusion). 6. Patient must have signed a consent form. 7. Patient affiliated to social security Exclusion Criteria: 1. Patient younger than 18 2. Impossibility to perform Balloon Kyphoplasty: * Technical impossibility to achieve the percutaneous approach to the vertebra to treat. * Vertebral pedicle diameter or height of treated vertebra(e) not sufficient regarding balloon kyphoplasty TROCATHETER size. This should be assessed through prescreening MRI and/or CT-Scan 3. More than three symptomatic vertebral compression fractures in the same vertebral segment. 4. Patient receiving additional local treatment within 15 days after balloon kyphoplasty procedure (surgery, radiofrequency, radiotherapy). 5. Patient with primary bone tumors (eg : osteosarcoma) or single solitary plasmocytoma (patients presenting those tumors on other parts of the body, other than VCF are eligible). 6. Patients presenting sclerotic or mixed vertebral lesions(sclerotic vertebral lesions at another vertebral level are not a contraindication). 7. Patients with less than 3 month life expectancy 8. Patient undergoing an experimental anti-cancerous treatment in Phase I evaluated at the same time 9. Patient having relevant co-morbidities which may interfere with the data management on pain and quality of life. 10. Patient presenting an inadequate vertebra with Balloon Kyphoplasty. 11. Patient undergoing an additional treatment other than balloon kyphoplasty for their vertebral fracture. 12. Patient presenting neurological signs or spinal cord compression or spinal canal narrowing requiring surgical decompression; 13. Patient with a medical or surgical condition not compatible with balloon kyphoplasty procedure (eg : a non-treated local infection) 14. Patient having an allergy to the bone cement and/or to the contrast media used during the balloon kyphoplasty procedure. 15. Pregnant or breast feeding women
References
Publications (0)
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