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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
Jean-Denis LAREDO, M.D.,PR.
Assistance Publique - Hôpitaux de Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)