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Percutaneous Vertebroplasty: Too Much Information? - Ryan Harvey, Bolt Burdon Kemp

27/09/18. It’s no secret that any treatment, be it surgical or conservative, may provide no therapeutic benefit to the patient. In light of a recent study into the efficacy of a routine treatment for osteoporotic spinal cord compression fractures, the question raised is if, and when, a patient should be informed of the existence of research which contradicts a traditionally held belief in a treatment’s efficaciousness?

Percutaneous vertebroplasty:

Percutaneous vertebroplasty, in brief, is a minimally invasive procedure involving the insertion of medical-grade cement into the vertebral spinal fracture. The cement solidifies stabilising the affected spinal vertebra. The intended effect is for a reduction, or relief, from the pain related to the fracture.

The use of percutaneous vertebroplasty to treat painful osteoporotic spinal fractures is supported by NICE in their guidance of April 2013 (reviewed last in January 2016). The guidance specifically recommends it as a treatment option for people who have: “severe ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management and in whom the pain has been confirmed to be at the level of fracture by physical examination and imaging.”

Buchibinder et al:

In April 2018, Buchbinder et al published a study following a systematic review into the effectiveness of

percutaneous vertebroplasty, as a treatment for osteoporotic spinal fractures.

The authors of the study found that, when compared against placebo, there is evidence to suggest a lack of clinically significant benefit against several criteria which include: pain, quality of life, and level of disability.

The recommendation of the study group was that all patients should be informed of the results of the study and for them to be made aware of the lack of evidence supporting the efficacy of percutaneous vertebroplasty to treat painful osteoporotic fractures.

This recommendation is intriguing and raises the question of whether recent research evidence should be provided to a patient as part of the consent process?

The practicalities:

There is considerable ongoing medical research being produced of varying applicability to a clinical setting. Not all research findings for each procedure can be provided to the patient at the consent stage. But is the provision of too much information a good enough reason to withhold the latest research evidence?

Post-Montgomery v Lanarkshire Health Board, there has been several landmark decisions on various issues related to consent. The 2017 the High Court judgement of Thefaut v Johnson may be the most indicative of the courts’ approach. The case highlighted the real need for accuracy when advising a patient of the potential benefit of a treatment. The same principle could be applied here to percutaneous vertebroplasty, in that for a patient to be adequately informed of the potential benefit they must also be informed of the latest evidence demonstrating a lack of efficacy.

Providing clarity over the benefit of any treatment is key to enable the patient to appropriately balance this against the material risks. Particularly in a procedure such as percutaneous vertebroplasty; albeit only a
minimally invasive procedure, the procedure is still associated with risks ranging from: infection, to leakage of cerebrospinal fluid, to spinal cord or nerve root compression. When assessed against the backdrop of

Buchbinder et al it begins to seriously raise the question of whether the benefit really does outweigh the risks.

It remains to be seen whether the medical community, and NICE, will consider adopting the recommendations of Buchbinder et al. In any event, it is important that high quality research evidence continues to underpin the recommendations and guidance of the medical community.

Ryan Harvey is a paralegal in the Spinal Injury team at Bolt Burdon Kemp.

References:

Buchbinder, R. Johnston, R.V., Richie, K.J., Komik, J., Allyson Jones, C,m Golmohammadi, K., Kallmes, D.F. (2018) Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Musculoskeletal Group.

National Institute for Health and Clinical Excellence (2013). Percutaneous vertebroplasty and percutaneous balloon kphoplasty for treating osteoporotic vertebral compression fractures (TA279).

Caselaw:

Montgomery v Lanarkshire Health Board [2015] UKSC 11.

Thefaut v Johnson [2017] EWHC 497. (QB)

Image cc http://www.flickr.com/photos/16848914@N05/2057231177/

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