The Future of Percutaneous Vertebroplasty; A Crack in the Cement?

July 2, 2018

Posted by: Ryan Harvey


Percutaneous vertebroplasty is a routine procedure commonly employed to treat painful spinal fractures, particularly those caused as a result of osteoporosis.  A study, published in April 2018 by Buchbinder, et al, has cast a cloud over the effectiveness of this procedure to provide pain relief.

With the recent news that a proposal has been made for the NHS to cease the funding of 17 operations on the grounds that they are outdated and ineffective [1] perhaps percutaneous vertebroplasty will be next on the list?

What is Osteoporosis?

Osteoporosis is a condition which affects over three million people in the UK alone [2].  The condition is characterised by an imbalance between the formation of ‘new bone’ with the breaking down of ‘old bone’.  Essentially, the bones are unable to form new bone cells at the same rate as the older bone cells are broken down.  This imbalance leads to a weakening of the bones, thereby increasing the likelihood of suffering from a bone fracture.  The most commonly observed fractures due to osteoporosis are of the wrist, hip and spinal vertebrae (the segmented bones of the spinal column).

Fractures of the spinal vertebrae associated with osteoporosis can be considerably painful. In such cases where there is a painful fracture of the spinal vertebrae, percutaneous vertebroplasty is considered as an option to help relieve the pain.

How does Percutaneous Vertebroplasty work?

In essence, it’s a minimally invasive procedure which involves the insertion of medical-grade cement through a needle directly into the vertebral spinal fracture.  The needle is removed and the cement hardens, which has the effect of stabilising the affected spinal vertebra.

Figure 1: Diagram to illustrate percutaneous vertebroplasty as used to treat spinal fractures.

https://premier-healthcare.eu/images/treatments/Spine/Vertebroplasty.jpg

Is Percutaneous Vertebroplasty effective?

In April 2018 a study was published by Buchbinder, et al [3] which assessed the role of percutaneous vertebroplasty as a treatment for osteoporotic spinal fractures (spinal fractures which are related to osteoporosis).

To assess how effective this treatment is, the group obtained data from several studies which compared patients suffering with painful osteoporotic spinal fractures and treated with percutaneous vertebroplasty compared to those who received a placebo treatment instead.

Following a review of all the data obtained, the authors were able to draw some intriguing conclusions when comparing the results of the treated population with that of the placebo population at one month post-treatment.

Among their findings were the following:

  1. Pain improved by 6% in the treatment group
  2. Disability improved by 7% in the treatment group
  3. Osteoporosis-specific quality of life improved by 3% in the treatment group
  4. Overall quality of life improved by 5% in the treatment group
  5. There was an increase of 9% in those who considered their treatment to have been a success (where pain relief is moderately or a great deal better) when compared to the placebo group

Though these findings trend towards the appearance of the treatment being beneficial, the reality is that these findings indicate that there is no clinically significant benefit to receiving percutaneous vertebroplasty one month after treatment.

This finding is of significance as procedures such as these always come with the risk of an adverse event occurring during, or following, surgery.  Potential complications that can arise from percutaneous vertebroplasty are: cement leakage into the blood stream; infection; leakage of cerebrospinal fluid; and spinal cord or nerve root compression.  If the risks outweigh any potential benefit then serious consideration of the future of the treatment needs to be made.

The authors of the study conclude that all patients should be informed of the results generated from this studybe made aware of  the evidence demonstrating the lack of efficacy of percutaneous vertebroplasty to treat pain.  It is my belief that this conclusion should be supported by the medical community.

Consent

Prior to any operation, one of the most important steps is the consenting process.  This is the term given to the ongoing dialogue between the surgeon and the patient where the patient is informed of all the potential benefits and any risks of the planned procedure.

The Spinal Injury team at Bolt Burdon Kemp have experience in acting for those who have undergone spinal cord procedures, and have investigated several claims where a patient was not adequately informed prior to surgery.  From our experience of investigating these cases, there can be negligence by medical staff in failing to adequately inform of all forseeable risks of a procedure.

It should be noted that most people who are treated with percutaneous vertebroplasty, as with any surgical procedure, have a positive outcome when the condition is identified and treated appropriately.  However, in rare and unfortunate situations, adverse events may occur which can result in new injuries and symptoms arising.  If you do find yourself in this position, the first course of action would be to speak to your doctor in order to better understand your injuries and to treat them appropriately.  But if you do find yourself with new injuries that you were not warned of prior to surgery, you may wish to seek legal advice as to whether these injuries could have been avoided.

Whilst it is not possible for all risks and potential complications to be foreseen, and for the patient to be informed of all eventualities, foreseeable risks should always be detailed so that a patient can be  aware of all potential outcomes.

As discussed earlier, the NHS are taking preliminary steps to eliminate the funding of  unnecessary procedures as part of a cost saving exercise.  Criticism of this approach has already arisen with patient leaders warning against “blanket bans” potentially denying treatment to those in need [4].

However, not all procedures do deliver the intended benefits consistently when balanced against the risk of the procedure.  Provided the patient remains the focus, and there is clinically appropriate, high quality, research to underpin these decisions to cease public funding of a procedure, it can be a positive step in the right direction for both the patient’s health and for securing the future of the NHS.

Ryan Harvey is a paralegal in the Spinal Injury team at Bolt Burdon Kemp.  If you or a loved one has suffered an injury or you are concerned about treatment received, contact Ryan free of charge and in confidence on 020 7288 4816 or at RyanHarvey@boltburdonkemp.co.uk.  Alternatively, complete this form and one of the solicitors in the Spinal Injury team will contact you.  Find out more about the Spinal Injury team.

References:

[1] Greenfield, P. “NHS wields the axe on 17 unnecessary procedures. The Guardian. 30 June 2018.

[2] NHS Choices. (2016, June). Osteoporosis. Retrieved from: https://www.nhs.uk/conditions/osteoporosis/

[3] 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.

[4] Smyth, C. “Health warning on NHS treatment ban.” The Times. 30 June 2018.

Posted by: Ryan Harvey

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