Percutaneous vertebroplasty seems to become the most common and effective technique for treating painful osteoporotic compression fractures of the spine. Principal Investigator, Dr Caroline Klazen from Department of Radiology, St Elisabeth Ziekenhuis, Tilburg, The Netherlands, presented details of a study currently underway assessing pain relief of patients suffering from osteoporotic vertebral compression fractures.
Osteoporosis is a worldwide problem with significant health and economic consequences, especially as the population ages. Elderly people tend to have progressive loss of bone mineral, leading to significantly higher rates of fragility fractures. The spinal vertebrae are also skeletal elements at risk to fracture. Osteoporotic vertebral compression fractures can be both asymptomatic or symptomatic, sometimes causing chronic pain and/or deformity.
Until recently, treatment options for osteoporotic compression fractures included the use of exercise, bed rest, physical sport and analgesia. However, such conservative therapy has failed to ease the pain for many sufferers. In these patients, percutaneous vertebroplasty can be the only solution for acute pain relief.
Speaking at CIRSE, Klazen discussed the 'VERTOS-II. Percutaneous vertebroplasty versus conventional therapy in patients with osteoporotic vertebral fractures' study that is currently underway. The study was initiated in November 2005 and is expected to be completed in November 2007.
Two hundred patients will be initially included in the multi-centre (five centres), prospective, randomised, interventional study to assess accurate pain relief, cost effectiveness, and complications of osteoporotic vertebral fractures, as well as secondary fractures. After a number of factors leading to the decrease in patient numbers (eg. decreasing pain and miscellaneous events such as dementia), 63 patients were randomised at baseline, 34 (11 male, 23 female) treated with percutaneous vertebroplasty (PV) and 29 (9 male, 23 female) with conservative therapy (CT).
According to Klazen, previous studies have been short in duration and have not had a comparison group of patients with usual care. The clinical research objectives of this study are to compare the effects (after one day, one week, one month, three months, six months and 12 months ) of vertebroplasty with conventional therapy on back pain, activities of daily living (ADL), mood, general health and quality of life (QoL).
Patients eligible for the study included both genders 50 years' of age and older, patients with a vertebral fracture in the thoracic region (T5) or lower, local back pain lasting for no longer than six weeks, bone oedema (visible with MRI, STIR sequence) and osteopenia or osteoporosis. Excluded patients were those with complete loss of vertebral body height, those suffering from osteomyelitis or spondylodiscitis, vertebral column neoplasms, pressure of bone fragments on the spinal cord, complete loss of vertebral height, uncorrectable coagulation disorder and medical conditions that would make the patient ineligible for decompressive surgery if necessary.
After one month, three months and 12 months, follow-up included X-rays of the thoracic/lumbar spine.
It was recorded that the number of vertebral compression fractures for the PV group caused by spontaneous fractures, trauma, and small trauma was 9, 1, and 24 respectively. In the CT group, the number of patients affected by these events were 11, 2, and 16 respectively.
Pain measurement
In the study, the Visual Analog Scale (VAS) was used to assess the level of pain. It was found that in the PV arm, the mean score of pain was 7.6 (+/- 1.7) and in the CT arm 7.5 (+/- 1.5), with a score of 10 representing the worst pain ever. The duration of pain at randomisation for the PV group was 34 days (+/- 18) and 32 days (+/- 17) for the CT group.
Procedure and conventional treatment
In the study, Klazen explained that patients in the PV arm received a transpedicular injection of polymethylmethacrylate (PMMA) bone cement, OsteoFirm (Cook), into the collapsed vertebral body using fluoroscopic guidance. Local anaesthetics was only required and the patient had the opportunity to return home on the same day. Patients in the CT group seeked advice from the general physician involved and it was then decided which analgesics were best to optimise pain relief for individual patients.
Economic evaluation
Klazen outlined that the purpose of the economic evaluation is to compare the differences in costs between vertebroplasty and usual care. Direct medical costs from resources such as GP visits, analgesics, physiotherapy and consultation of orthopaedic surgeons and GPs are recorded, and actual costs ie. unit costs, estimated. The main outcome for this evaluation is to assess adequate relief of pain, measured by the VAS. Relief of up to 3.0 to 4.4 points is considered adequate, says Klazen. Additionally, pain health related to quality of life was also measured.
Conclusion
Following from the positive short-term results from the Vertos 1 study, which was a randomised, controlled trial assessing PV vs. CT in 34 patients (18 PV, 16 CT), the Vertos 2 trial so far has demonstrated successful randomisation. As Klazen explained, the results from Vertos 1 showed effective pain relief and improvement of mobility, function and stature after PV is immediate and significantly better short-term in comparison to CT. The Vertos 2 study will be finalised by the end of 2007 and is predicted to demonstrate positive outcomes in terms of pain relief and cost effectiveness.
Published: Nov 2006
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