What is the Balloon Kyphoplasty procedure?
Balloon Kyphoplasty is a minimally-invasive procedure for the treatment of patients with painful vertebral compression fractures (VCFs), that helps reduce spinal (or vertebral) deformity and repair the break in the vertebral body to reduce pain and improve quality of life .
The procedure involves two small incisions in the skin and insertion of two small, very strong balloons into the fractured bone. The balloons are inflated inside the fractured vertebral body to return it to its normal position. Once the vertebral body is in the correct position, the balloons are deflated and removed, creating space to inject special bone cement at low pressure. As the cement sets, it stabilises the affected vertebra and reduces vertebral deformity.
Balloon Kyphoplasty has been shown to correct spinal deformity, providing fast and sustained pain relief to the patient, leading to improvement in the ability to perform daily living activities and improved quality of life. Increased mobility generally enables patients to return to everyday activities such as walking, bending, and lifting, with significantly less pain than prior to the procedure. This allows improved vitality, social life, and emotional well-being.
Who benefits from Balloon Kyphoplasty?
Patients with VCFs due to osteoporosis, metastatic cancers, multiple myeloma or trauma could benefit from Balloon Kyphoplasty. There are approximately three million people in the UK suffering from osteoporosis. It can affect people of all ages but one in two women and one in five men over the age of 50 will break a bone mainly because of osteoporosis. There are an estimated 230,000 osteoporotic fractures every year in the UK, and 120,000 of these are vertebral fractures. Alarmingly, an estimated two-thirds of all vertebral fractures remain undiagnosed or untreated due to difficulty in determining the cause of symptoms or sometimes to the absence of acute pain. There is a clear need for earlier diagnosis of VCFs, to allow earlier and more effective treatment.
Balloon Kyphoplasty: Proven Clinical Track Record
Balloon Kyphoplasty is the subject of the largest randomised controlled clinical trial in surgical management of VCFs, which demonstrated superior patient outcomes compared to non-surgical management (including analgesia, bed rest, physiotherapy and back bracing)1. The results from the trial published in The Lancet (2009) show that patients treated with Balloon Kyphoplasty benefit from superior pain reduction, physical function and quality of life more rapidly than those treated with non-surgical management. (See www.freetobefree.eu for details of this study)
The research indicated that VCF patients treated with non-surgical management suffered a severe loss of quality of life. However, patients who received Balloon Kyphoplasty treatment had a similar quality of life to age matched people without osteoporosis.
Other published studies report a marked reduction in pain, sometimes within hours of the procedure.
Since 2000, there have been more than 500,000 patients successfully treated with Balloon Kyphoplasty worldwide.
What happens during the Balloon Kyphoplasty procedure?
The Balloon Kyphoplasty procedure can be undertaken under general anaesthesia or conscious sedation and takes up to one hour to perform.
The procedure can be performed during a day stay, or with an overnight stay, dependent on medical need. Balloon Kyphoplasty involves low pressure to deliver thick bone cement in the defined cavity which therefore reduces the risk of cement leakages. Compared to vertebroplasty, Balloon Kyphoplasty has a significantly lower leakage rate.
Step 1: Balloon Placement
Through small incisions, two narrow canullae are inserted into the fractured bone and two balloons are inserted.
Step 2: Balloon Inflation and cavity creation
The two balloons are carefully inflated to raise the collapsed vertebral body and return it to its normal position. Once the vertebral body is in the correct position, the balloons are deflated and removed. Balloon inflation creates a cavity within the vertebral body by compacting the soft, inner bone.
Step 3: Cavity Fill
The resulting cavity is filled with bone cement to stabilise the fracture. This is done using a special thick cement and very low pressure2 to reduce the risk of cement leakages.
Step 4: Internal Cast
The bone cement forms an internal cast that holds the vertebral body in place. Stabilisation of the fracture should reduce the pain experienced by the patient.
When should Balloon Kyphoplasty be used?
Recent data published in The Lancet suggests that earlier treatment with Balloon Kyphoplasty should be considered. The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Balloon Kyphoplasty for vertebral compression fractures in January 2008 supporting its use in patients with VCFs.
The growing bank of clinical data for Balloon Kyphoplasty should help inform treatment decisions and encourage earlier consideration of Balloon Kyphoplasty for patients with spinal fractures.