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 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?

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 below-kyphoplasty 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 Kyphoplasty 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. 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 Cheaper Quicker Expensive Takes longer Restoration of vertebral height? Less adjacent fractures Less cement leakage Quality of life

Vertebroplasty v Kyphoplasty A review of 168 studies. Mean change in VAS 5.68 New fracture 17.9% Cement leak 19.7% 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.