Kyphoplasty and Vertebroplasty in vertebral fractures Kyphoplasty and Vertebroplasty • • • • • • • Epidemiology of osteoporotic fractures Natural history Morbidity and mortality Conservative treatment Vertebroplasty/Kyphoplasty How its done Selection of patients and imaging Kyphoplasty and Vertebroplasty • • • • • • Results Vertebroplasty v Kyphoplasty Acute v Chronic fractures Controversies Other indications Future developments Epidemiology Radiographic • 25 % in post menopausal females • 40% in women > 80yrs • Age group 65 yrs+ are fastest growing segment of the population • Less common in men • Melton et al. Epidemiology of vertebral fractures in women. Am J Epidemiol 1989; 129:1000-11. Consequences of vertebral fractures • Sentinel sign of failing health • 35-40% increase in cancer deaths • 23-34% increase in mortality rates • 5yr survival 61% cf. 76% • Cooper C et al. Population based study of survival after osteoporotic fractures. Am J Epidemiol 1993:137;1001-5. Clinical incidence • Majority are asymptomatic • Loss of height and stooped posture • 23-33% are painful • Over ⅔rds become manageable or asymptomatic in 6-12 weeks • Cooper C et al. The epidemiology of vertebral fractures. Bone 1993-14.611-5 Predictors of fracture • • • • • • • Age Sex Osteoporosis Inactivity Smoking 20-30% are multiple Previous fracture Predictors of fracture Predictors of fracture 19.2% of females with a confirmed incidental fracture had a second fracture within one year. 24% of females with two or more fractures developed a further fracture within a year. Lindsay et al. JAMA 2001; 285: 320-3. Evaluation • Severe back pain • Often no history of trauma • Pain is worse upright • Thoracic kyphosis • Pain reproduced by pressure over spinous process • Very rare neurological deficit • Exclude other causes Evaluation Think twice! • Fractures above T6 • Less than 55 yrs without history of trauma • Patients with known malignancy Radiographic evaluation of age of fracture • Plain films • MRI Low signal T1 High signal T2 High signal STIR Best indicator of age is the history. Bone Scan • Not as commonly used as MRI • Been show to have a 93% predictive value in vertebroplasty! • May be abnormal when MRI is normal • Maynard et al. Value of bone scan imaging in predicting pain relief in vertebroplasty. AJNR 2000;21:1807-12. Treatment • • • • • Pain relief Exercise Diet Osteoporosis Brace? Vertebroplasty / Kyphoplasty What is it? Vertebroplasty Kyphoplasty How does it work? • Structural support – but no good correlation with amount of cement injected • Thermal properties • Decompression • Placebo How is it done? • Usually performed under general anaesthetic • Can be performed under local • Day case procedure • Minimal invasive How is it done? How is it done? How is it done? Vertebroplasty Kyphoplasty How is it done? Indications for vertebroplasty/kyphoplasty • Only needed in a small subset of patients • High signal on STIR. • Pain on percussion • Increased activity on bone scan • T5 and belowkyphoplasty • Timing? Contraindications • Infection • Uncorrectable coagulopathy • Anaesthetic Risk • Neurology • Middle column compromise is NOT. Complications • Very few cliniccal relevant complications. • Cement extravasation 70%+ • Pulmonary embolus 70%+ Results Vertebroplasty • Significant better pain and functional improvement than conservative treatment at 3 months. • No difference at twelve months. • Vertebroplasty patients had significantly more pain than the conservative group. • Hulme PA et al. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies. Spine 2006:31;1983-2001. Kyphoplasty • FREE trial. • 300 patients randomised. • Assessed at one year • SF 36 PCS 0-100. • Kyphoplasty 26 33.4 • Conservative 25.5 27.4 p<0.0001 Wardlaw D et al Lancet 2009;21:1016-24 Controversies No Benefit • A Randomized Trial of Vertebroplasty for painful Osteoporotic Vertebral Fractures • Buckbinder R et al. NEJM 2009;361:557-568. • A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures • Kalmes DF et al. NEJM 2009;361: 569-579. • No improvement against sham procedure at 1 week, or at 1,3 or 6 months. Controversies No Benefit • Previous studies – lack of blinding, lack of true sham control. Couldn’t exclude a placebo effect. • NEJM studies- randomised, blinded and a sham procedure. Buckbinder needle against lamina. Kalmes – local anaesthetic around the facet joint. Problems Fracture acuity Buckbinder: bone marrow oedema indicates an acute fracture but a detectable fracture line sufficed for inclusion. Kalmes only used MRI or Bone scan in which fracture age was uncertain. • Both groups had to have a fracture less than a year old- most groups would use 6 weeks as an acute fracture definition. Problems Enrollment • Kalmes: 1812 patients initially screened,only 131 entered into study. Most common reason – patient refusal. • Buckbinder: Needed 4.5 years in 4 high volume centres to accrue 78 patients- 141 declined randomisation. • Pain severity of groups who refused not reported. Problems Control Group • Is injection of local anaesthetic around the facet joint a sham procedure? Vertos II Study • Prospective randomised trial vertebroplasty v conservative treatment. 202 patients. • Results Vertebroplasty had better pain relief at one year. • All fractures less than six weeks old. • Klazen C et al Lancet 2010:376;1085-1092. Timing • The best evidence is that the best results are achieved within 6 weeks of onset! • Rarely achievable in the UK • 50% + get better within 6 weeks conservatively treated. • Philosophical when to treat. • Most fractures treated in UK > 3 months old. Timing Older fractures • No randomised control trials for efficacy of treatment of old fractures. • There are trials suggesting similar success rates to acute fractures of 80% success in fractures a year or older. • Brown et al. Treatment of Chronic symptomatic vertebral compression fractures with percutaneous vertebroplasty . AJN 2004;182:319-312. My protocol • Fractures less than 6 weeks old who need to be hospitilised. • Failure of conservative treatment after 3 months • Vertebroplasty for all except where middle column is involved – Kyphoplasty, • Bone scan +ve Vertebroplasty v Kyphoplasty Vertebroplasty • Cheaper • Quicker Kyphoplasty • Expensive • Takes longer • Restoration of vertebral height? • Less adjacent fractures • Less cement leakage • Quality of life Vertebroplasty v Kyphoplasty A review of 168 studies. Vertebroplasty • Mean change in VAS 5.68 • New fracture 17.9% • Cement leak 19.7% Kyphoplasty • Mean change in VAS 4.60 p<0.001 • New fracture 14.1% p<0.01 • Cement leak 7.0% p<0.001 • Comparison of vertebroplasty and kyphoplasty in vertebral compression fractures: a meta-analysis of the literature. Spine J 2008;8:488-97. Other Uses • Tumours • Trauma • Myeloma Other uses • Sacroplasty • Sacral insufficiency fractures • Best performed under CT guidance. Developments • Calcium phosphate in young patients with traumatic fractures • Prophylaxis • Adding chemotherapy agents or radioactive isotopes to the cement in tumour Conclusions • Vertebroplasty/Kyphoplasty is useful in the treatment of vertebral osteoporotic fractures although some controversy still exists. • Low morbidity • Should be considered in painful fractures over 6 weeks old.