Kyphoplasty and Vertebroplasty in vertebral fractures

1. Kyphoplasty and Vertebroplasty in vertebral fractures

2. Kyphoplasty and Vertebroplasty • Epidemiology of osteoporotic fractures • Natural history • Morbidity and mortality • Conservative treatment • Vertebroplasty/Kyphoplasty • How its done • Selection of patients and imaging

3. Kyphoplasty and Vertebroplasty • Results • Vertebroplasty v Kyphoplasty • Acute v Chronic fractures • Controversies • Other indications • Future developments

4. EpidemiologyRadiographic • 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.

5. 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.

6. 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

7. Predictors of fracture • Age • Sex • Osteoporosis • Inactivity • Smoking • 20-30% are multiple • Previous fracture

8. 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.

9. 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

10. Evaluation Think twice! • Fractures above T6 • Less than 55 yrs without history of trauma • Patients with known malignancy

11. Radiographic evaluationof age of fracture • Plain films • MRI Low signal T1 High signal T2 High signal STIR Best indicator of age is the history.

12. 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.

13. Treatment • Pain relief • Exercise • Diet • Osteoporosis • Brace?

14. Vertebroplasty / KyphoplastyWhat is it? Vertebroplasty Kyphoplasty

15. How does it work? • Structural support – but no good correlation with amount of cement injected • Thermal properties • Decompression • Placebo

16. How is it done? • Usually performed under general anaesthetic • Can be performed under local • Day case procedure • Minimal invasive

17. How is it done?

18. How is it done?

19. How is it done? Vertebroplasty Kyphoplasty

20. How is it done?

21. 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?

22. Contraindications • Infection • Uncorrectable coagulopathy • Anaesthetic Risk • Neurology • Middle column compromise is NOT.

23. Complications • Very few cliniccal relevant complications. • Cement extravasation 70%+ • Pulmonary embolus 70%+

24. Results Vertebroplasty 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 • 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.

25. ControversiesNo 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.

26. 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.

27. ProblemsFracture 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.

28. ProblemsEnrollment • 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.

29. ProblemsControl Group • Is injection of local anaesthetic around the facet joint a sham procedure?

30. 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.

31. 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.

32. TimingOlder 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.

33. 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

34. Vertebroplasty v Kyphoplasty Vertebroplasty Kyphoplasty Expensive Takes longer Restoration of vertebral height? Less adjacent fractures Less cement leakage Quality of life • Cheaper • Quicker

35. Vertebroplasty v KyphoplastyA review of 168 studies. Vertebroplasty 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. • Mean change in VAS 5.68 • New fracture 17.9% • Cement leak 19.7%

36. Other Uses • Tumours • Trauma • Myeloma

37. Other uses • Sacroplasty • Sacral insufficiency fractures • Best performed under CT guidance.

38. Developments • Calcium phosphate in young patients with traumatic fractures • Prophylaxis • Adding chemotherapy agents or radioactive isotopes to the cement in tumour

39. 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.