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Vertebral augmentation for painful osteoporotic vertebral fractures

Vertebral augmentation for painful osteoporotic vertebral fractures

Best Practice Guidance

How up to date is this information?

Published January 2020 | Last reviewed September 2024


Using this guidance

The guidance set out here was reviewed extensively in the Autumn of 2024. There are no plans for any further reviews.

Medicine is constantly evolving and over time it is inevitable that the evidence base will change. Please use your own judgement and/or other sources of clinical guidance alongside the information set out here.

Please note this guidance is a recommendation and it should be used in the context of the overall care pathway and when all alternative interventions that may be available locally have been undertaken.

Summary

Osteoporotic bones are of reduced density and are more susceptible to fractures. Vertebral compression fractures are a break in a bone of the spinal column that results in a reduction in height of that bone. Osteoporotic vertebral fractures can cause pain and potentially an associated reduction in mobility. The pain can often improve as healing occurs. Deformity and respiratory or gastrointestinal disturbance as a result of fractures may be permanent.

Vertebral augmentation, including vertebroplasty (VP) and kyphoplasty (KP), refers to spinal procedures which involve the injection of bone cement (typically polymethylmethacrylate (PMMA)) into the fractured vertebral body via a needle inserted through the skin, using image guidance). These procedures aim to increase stability and strengthen the bone with the intention of reducing pain and further collapse. The procedure can be performed under local anaesthetic with sedation, or general anaesthesia interventional radiologist, spinal surgeon or pain specialist. Decisions regarding the need for vertebral augmentation are made by the operator, in conjunction with metabolic and pain specialists, geriatricians and the patient.

The alternative to vertebral augmentation is conservative management. This consists of pain relief, bracing, and manual therapy, although the evidence for bracing and manual therapy has shown to be of no benefit. Bone healing can take place over 2-12 weeks. Hospitalisation, immobility and opioid pain medication often have significant side effects, particularly in older patients.

The majority of older hospitalised patients treated conservatively still have significant pain at three months and over one third at six months.

 

This guidance applies to adults aged 19 years and over.

Recommendation

Vertebroplasty (VP) or kyphoplasty (KP) should be offered as a treatment for painful osteoporotic vertebral fractures on a case-by-case basis. As per advice in the NICE Technology Appraisal Guidance 279 (TAG 279), VP or KP may be considered:

  • In cases where patients have ‘severe (7/10 or greater on VAS scale) ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management’ and in particular hospitalised older people
  • Where the acute vertebral fracture has been proven on imaging and correlates with the site of maximal pain on clinical examination
  • The decision to treat should be taken after multidisciplinary team discussion
  • The procedure should take place at a facility with access to spinal surgery services
  • Processes for audit and clinical governance should be in place
  • VP/KP must be performed in conjunction with additional measures to improve bone health.

NICE TAG 279 delegates the eligible timeframe for intervention to the clinician. However, evidence from a 2016 randomised controlled trial (RCT) offers evidence that older patients (>60 years old) with fractures at most 6 weeks old and severe pain despite optimal pain management that benefit most from the procedure.

Rationale for recommendation

The evidence for VP in the management of vertebral compression is heterogeneous in population, comparators and outcomes. In 2013 and 2016 NICE TAG 279 reviewed the available evidence. NICE stated that the available open label randomised controlled trials comparing VP with conservative management better reflected the clinical reality. These studies demonstrated improvement in pain post VP. NICE acknowledged double blind RCTs which had demonstrated no significant improvement post VP but felt these to be less relevant.

Since 2016, two further double blind RCTs assessing VP compared to sham procedure have been completed. A 2016 RCT with more specific inclusion criteria (including patients over 60 years old, with fractures less than 6 weeks old and severe pain despite medication). compared VP with subcutaneous local anaesthetic. It demonstrated improved pain management in VP. A 2018 RCT, which included fractures up to 9 weeks old demonstrated no difference between VP and periosteal injection of local anaesthetic.

A 2018 Cochrane systematic review stated that there was no evidence to support the use of VP in painful osteoporotic fractures. However, this review has been subject to criticism. NICE TAG 279 and a number of publications since 2016 have shown a reduction in mortality in those treated with VA as opposed to conservative management.

Currently, there is no convincing body of evidence to alter the stance of the NICE TAG 279. There is general agreement that further adequately powered trials are needed for further assessments of subgroups, particularly hospitalised older people.

VAPOUR (2016) showed a significant reduction in length of stay for their inpatient cohort. Risk of serious adverse event following VA is rare. VA has not shown to cause an increase in additional/adjacent vertebral fractures.

It is clear that aggressive treatment of the underlying osteoporosis is paramount.

Patient information

There is no specific EBI patient guidance for this intervention.

However, we recommend using the BRAN principles (Benfits, Risks, Alternatives and do Nothing) when speaking with patients about this.

Further information on patient involvement in EBI can be found on the EBI for patients section.

 

 

Coding

WHEN LEFT(Primary_Spell_Procedure,4) in ('V444','V445') 
AND Primary_Spell_Diagnosis LIKE '%M80[01234589]%' 
-- Age between 19 and 120
AND ISNULL(APCS.Age_At_Start_of_Spell_SUS,APCS.Der_Age_at_CDS_Activity_Date) between 19 AND 120 
THEN '2V_vertebroplasty'
Exclusions
WHERE 1=1
-- Cancer Diagnosis Exclusion
AND (Any_Spell_Diagnosis not like '%C[0-9][0-9]%' 
AND Any_Spell_Diagnosis not like '%D0%' 
AND Any_Spell_Diagnosis not like '%D3[789]%' 
AND Any_Spell_Diagnosis not like '%D4[012345678]%' 
OR Any_Spell_Diagnosis IS NULL)
-- Private Appointment Exclusion
AND apcs.Administrative_Category<>'02'

References

  1. Nice Technology Appraisal Guidance (2013) Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures [TA279].
  2. Clark W, Bird P, Gonski P, Diamond TH, Smerdely P, McNeil HP, Schlaphoff G, Bryant C, Barnes E, Gebski V. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, doubleblind, placebo-controlled trial. The Lancet. 2016 Oct 1;388(10052):1408-16.
  3. Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. Journal of Neurosurgery: Spine. 2011 May 1;14(5):561-9.
  4. Voormolen MH, Mali WP, Lohle PN, Fransen H, Lampmann LE, Van der Graaf Y, Juttmann JR, Jansssens X, Verhaar HJ. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. American Journal of Neuroradiology. 2007 Mar 1;28(3):555-60.
  5. Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. The Lancet. 2010 Sep 25;376(9746):1085-92.
  6. Blasco J, Martinez‐Ferrer A, Macho J, San Roman L, Pomés J, Carrasco J, Monegal A, Guanabens N, Peris P. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12‐month randomized follow‐up, controlled trial. Journal of Bone and Mineral Research. 2012 May;27(5):1159-66.
  7. Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine. 2009 Jun 1;34(13):1349-54.
  8. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. New England Journal of Medicine. 2009 Aug 6;361(6):557-68.
  9. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W. A randomized trial of vertebroplasty for osteoporotic spinal fractures. New England Journal of Medicine. 2009 Aug 6;361(6):569-79.
  10. Firanescu CE, de Vries J, Lodder P, Venmans A, Schoemaker MC, Smeet AJ, Donga E, Juttmann JR, Klazen CA, Elgersma OE, Jansen FH. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. bmj. 2018 May 9;361:k1551.
  11. Buchbinder R, Johnston RV, Rischin KJ, Homik J, Jones CA, Golmohammadi K, Kallmes DF. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database of Systematic Reviews. 2018(11).
  12. Clark W, Bird P, Diamond T, Gonski P, Gebski V. Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients. BMJ evidence-based medicine. 2019 Mar 9:bmjebm-2019.
  13. Tsoumakidou G, Too CW, Koch G, Caudrelier J, Cazzato RL, Garnon J, Gangi A. CIRSE guidelines on percutaneous vertebral augmentation. Cardiovascular and interventional radiology. 2017 Mar 1;40(3):331-42
  14. Position Statement on Percutaneous Vertebral Augmentation John D. Barr, MD et al.
  15. Firanescu C, de Vries J, P Lodder, Venmans A, Schoemaker M, Smeets M, Donga E, Juttmann J, Klazen C, Elgersma O, Jansen F, Tielbeek A, Boukrab I, Schonenberg K, van Rooij WJ, Hirsch J, Lohle P. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. 2018 May 9: 361:k1551.
  16. Orthosis in Thoracolumbar Fractures – A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Daniela Linhares Bernardo Sousa Pinto, Manuel Ribeiro da Silva, Nuno Neves, João A Fonseca Spine (Phila Pa1976) 2020 Aug 26.
  17. Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT. Barker KL, Newman M, Stallard N, Leal J, Minns Lowe C, Javaid MK, Noufaily A, Adhikari A, Hughes T, Smith DJ, Gandhi V, Cooper C, Lamb SE. Health Technol Assess. 2019 Aug;23(44):1-318. doi: 10.3310/hta23440.
  18. The Nottingham Spinal Health (NoSH) Study: a cohort study of patients hospitalised with vertebral fragility fractures. T. Ong, O. Sahota & J. R. F. Gladman. Osteoporosis International volume 31, pages363–370(2020).