Status:
TERMINATED
Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Vertebral Fracture
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 fra...
Detailed Description
Vertebral compression fractures (VCF) represent an important source of morbidity in patients presenting osteolytic metastatic or myelomatous vertebral involvement. In addition, cancer treatments may i...
Eligibility Criteria
Inclusion
- Male or female, 18 years or older
- 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 ;
- The pain related to the fractured vertebrae is the more prevalent
- More than 3 months life expectancy.
- Blood Platelets rate more than or equal to 50 000/mm3 within the week before balloon kyphoplasty procedure (after a correct blood transfusion).
- Patient must have signed a consent form.
- Patient affiliated to social security
Exclusion
- Patient younger than 18
- 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
- More than three symptomatic vertebral compression fractures in the same vertebral segment.
- Patient receiving additional local treatment within 15 days after balloon kyphoplasty procedure (surgery, radiofrequency, radiotherapy).
- 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).
- Patients presenting sclerotic or mixed vertebral lesions(sclerotic vertebral lesions at another vertebral level are not a contraindication).
- Patients with less than 3 month life expectancy
- Patient undergoing an experimental anti-cancerous treatment in Phase I evaluated at the same time
- Patient having relevant co-morbidities which may interfere with the data management on pain and quality of life.
- Patient presenting an inadequate vertebra with Balloon Kyphoplasty.
- Patient undergoing an additional treatment other than balloon kyphoplasty for their vertebral fracture.
- Patient presenting neurological signs or spinal cord compression or spinal canal narrowing requiring surgical decompression;
- Patient with a medical or surgical condition not compatible with balloon kyphoplasty procedure (eg : a non-treated local infection)
- Patient having an allergy to the bone cement and/or to the contrast media used during the balloon kyphoplasty procedure.
- Pregnant or breast feeding women
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00748631
Start Date
October 1 2007
End Date
November 1 2010
Last Update
March 24 2015
Active Locations (4)
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1
Hôpital Henri Mondor - Service de Radiologie
Créteil, Val de Marne, France, 94000
2
Hôpital Lariboisière-service de radiologie ostéoarticulaire
Paris, France, 75010
3
Hôpital Cochin - service de radiologie
Paris, France, 75014
4
Hopital Bichat -service de radiologie
Paris, France, 75018