Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"
18 Years
N/A
Both
Vertebral Fracture, Multiple Myeloma, Osteolytic Metastases
Trial Information
Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"
Vertebral compression fractures (VCF) represent an important source of morbidity in patients
presenting osteolytic metastatic or myelomatous vertebral involvement. In addition, cancer
treatments may induce osteoporosis with an additional risk of vertebral fractures.
- Current medical treatments are symptomatic. They do not treat the fracture itself.
- Vertebroplasty is an interventional radiological technique that consists of injecting,
percutaneously, acrylic cement into the fractured vertebra under radiological guidance
and local or general anaesthesia, in order to combine two effects: stabilization of the
vertebral body fracture and pain reduction.
- Balloon Kyphoplasty is a variant of vertebroplasty which is performed using the KyphX®
System (Medtronic., Sunnyvale, California). Balloon kyphoplasty aims at restore
vertebral height of the fractured vertebra using an inflatable balloon prior to inject
surgical polymethylmetacrylate (PMMA)cement,into the vertebral body to fix the
fracture. It is an expensive technique costing around 4,000 euros for up to 2 vertebrae
in the same patient. The surgical technique for the procedure has been described by
LIBERMEAN et al: A bilateral approach is usually chosen to insert working cannulas
into the posterior part of the vertebral body through a posterior transpedicular
approach. In case of limited and asymmetric vertebral destruction, a single unilateral
approach may be preferred. Fluoroscopy is used to insert the tools and control the
procedure. With reaming tools, two working channels are created and the balloons are
inserted. The balloons are available in lengths of 10, 15 and 20 mm.
The two balloons (one on each side) should ideally be centered at middle height between the
superior and inferior endplates and in the anterior two-thirds of the vertebral body.
Balloon placement into the vertebral body is checked using radiopaque markers at the two
extremities of the balloon. Once inserted, the balloons are inflated using visual, volume
and pressure control to create a cavity. Inflation is stopped when one of the following
inflation endpoints is reached: pressure raised over 400 psi, balloon contacts one of the
cortical bone of the vertebra or reaching maximal balloon inflation volume. The balloons
are then deflated and removed. The mean balloon inflation volume is 2 to 3ml. The Bone
Filler Device, filled before with 1.5 ml of PMMA, is then advanced through the working
cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless
steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler
Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced
through the working cannula. This step is repeated till a complete fill of the cavity is
obtained. The same procedure is repeated through the other working cannula at the
contra-lateral pedicle. Filling of the cavity with highly viscous PMMA is performed under
continuous fluoroscopic control.
The aim of this study is to quantify the analgesic and patient function improvement of
Balloon Kyphoplasty together with complication types and rate in patients with malignant
vertebral fractures due to metastatic disease or multiple myeloma.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome 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).
Outcome Time Frame:
day 15
Safety Issue:
Yes
Principal Investigator
Jean-Denis LAREDO, M.D.,PR.
Investigator Role:
Study Director
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
P050323
NCT ID:
NCT00748631
Start Date:
October 2007
Completion Date:
November 2010
Related Keywords:
- Vertebral Fracture
- Multiple Myeloma
- Osteolytic Metastases
- Vertebral fracture
- Vertebral compression fracture
- Multiple Myeloma Bone marrow diseases
- Vertebral metastases
- Balloon Kyphoplasty
- Fractures, Bone
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasm Metastasis
- Spinal Fractures
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