Will vertebroplasty come good?
Terence Ong is a Consultant Geriatrician at Queens Medical Centre, Nottingham University Hospitals NHS Trust.
Over 500 publications in the last 5 years including an updated Cochrane review published early this year on vertebroplasty has not quelled the debate if it is an effective treatment for painful vertebral fragility fractures. The Cochrane review was very clear that vertebroplasty offered little benefit in reducing pain and disability when it was compared with a placebo (sham procedure). So, why are there still proponents of the intervention? Are they rebellious clinicians with little regard for evidence-based medicine still clinging on to the hope that one day vertebroplasty will come good?
Up till the simultaneous publication of two vertebroplasty-placebo trials in 2009, the benefits of vertebroplasty were consistently reported in published literature and supported by what was seen in clinical practice. It is generally agreed that studies using a placebo, in this case one that mimics the vertebroplasty experience, produces a higher level of confidence in its findings. To date, there has been five such studies (4 published in peer-reviewed journals) which recruited almost 550 participants with acute vertebral fragility fractures. Analysed together, it showed little benefit compared to a sham procedure.
Findings from systematic reviews depend on the individual studies that contribute to it. It is worth noting that out the five studies, one did demonstrate a benefit with vertebroplasty which begs the question what was different about it. All clinical trials have limitations and unsurprisingly for such a debatable topic, much has been published critiquing [See citations 2, 3, 4, 5] and supporting [6, 7] these trials. In summary, critique of the no-benefit trials commented that the vertebroplasty procedure did not mirror clinical practice (e.g. low volume of cement used), the sham procedure that was not truly a placebo but an active intervention, and patient enrolment issues. Even the one trial that reported benefit was challenged on its reporting transparency.
Personally, I am yet sold that vertebroplasty is no better than a placebo because the studies included in the Cochrane review did not reflect the cohort of patients I look after. I work in an acute hospital where the patients I look after are most symptomatic from their fractures. Their pain is not just high on a scale but crippling. Being physically inactive due to severe pain for days is similar to untreated hip fractures. The majority of participants in the vertebroplasty-placebo studies were recruited from an outpatient setting (one study did not recruit hospital patients at all) with pain duration longer than 6 weeks. Their reported pain score on average was at least 7/10. Just as clinicians would not treat an older person’s high blood pressure based on a reading alone, one would not select patients for intervention based on a pain score which does not truly capture the severity of one’s pain. Acute oedema on MRI helps decide if the fracture was recent but does not correlate with symptoms and is not a predictor of vertebroplasty outcomes. The study that demonstrated a benefit recruited most participants from a hospital setting with most fractures occurring 3 weeks prior to admission. A group of participants more akin to the one I see in hospital.
Besides that, several issues remain unresolved. Vertebroplasty is a minimally invasive procedure and any benefit is likely operator and procedure dependent. Evidence these last few years has suggested that cement volume and rate which was a contentious issue was associated with outcomes. Standardising an agreed placebo procedure would also help better interpret the findings.
I agree with the Cochrane review that despite reporting significant pain, patients that can still be managed in an outpatient setting would not derive much benefit from vertebroplasty. However, questions remain to help me inform my clinical if it has a role in the group of patients I look after. Is vertebroplasty an effective treatment to improve outcomes, such as time to mobilisation, opioid requirement, length of hospital stay or discharge destination? Or is it like what has been reported so far, just a pretty good placebo effect.
- Buchbinder R, Johnston RV, Rischin KJ, Homik J, Jones C, Golmohammadi K, Kallmes DF. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database of Systematic Reviews 2018, Issue 4. Art. No.: CD006349. DOI: 10.1002/14651858.CD006349.pub3
- Clark WA, Diamond TH, McNeill P, Gonski PN, Schlaphoff GP, Rouse JV. Vertebroplasty for painful acute osteoporotic vertebral fractures: recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty. MJA 2010 192:334-337
- Bono CM, Heggeness M, Mick C, Resnick D, Watters WC. Newly released vertebroplasty randomized controlled trials: a tale of two trials. Spine J 2010 10(3):238-240
- Clark WA. Re: No more vertebroplasty for acute vertebral compression fractures? BMJ 2018;361:k1756 [accessed 24 Aug 2018]
- Rapid responses. BMJ 2018;361:k1551 [accessed 24 Aug 2018]
- Buchbinder R, Osbourne RH, Kallmes D. Invited editorial presents an accurate summary of the results of two randomised placebo-controlled trials of vertebroplasty. MJA 2010. 192:338-341
- Miller FG, Kallmes D, Buchbinder R. Vertebroplasty and the placebo response. Radiology 2011. 259:621-625
- Buchbinder R, Kallmes D, Jarvik J, Deyo RA. Conduct and reporting of a vertebroplasty trial warrants critical examination. Evid Based Med 2017. 22(3):106-107