By definition, it is often difficult to get decent comparative data on new technologies especially for orthopaedic procedures. However, it is interesting to see how the FREE Study compared the outcomes for different approaches in treating spine fractures. Consultant Orthopaedic Surgeon Khai Lam, who was also a medical investigator for the study, summarises the findings and adds his own view on how well patients responded:
The FREE (Fracture Reduction Evaluation(25) trial is a landmark study because it is the first and largest, randomised control trial comparing BKP to non-surgical care (control) in the treatment of acute painful osteoporotic VCFs. The study of 300 patients at 21 centres in eight countries was published in the Feb 24 online edition of The Lancet and shows that BKP provided statistically significant better outcomes compared to controls.
In terms on quality of life as measured by SF-36 PCS (physical component summary), BKP patients improved during the year by an average of 3.5 points greater than controls (P<0.0004 versus baseline). For EuroQol-5D, BKP patients improved from baseline more than controls at 1 (P<0.0003) and 12 months (P<0.025).
In terms of back pain function and mobility, the Roland Morris Score improved by 4.0 (P<0.0001) and 2.6 points (P=0.0012) at their respective 1 and 12 months follow up. There was a reduction by an average of 2.5 days per 2 weeks during the year (P<0.0001) when measuring restricted activity days.
The visual pain analogue scale (VPAS) decreased by an average of 2.2 and 0.9 points (both P<0.001) in the BKP group at their respective 1 and 12 months follow up time points. Narcotic use was also reduced significantly at both the 1 and 6 months (both P< 0.05).
We were one of the investigator sites and contributed a number of patients to this study. As a regional centre we have treated many such patients and we now extend this treatment option to effectively treat malignant cancers that have spread to the spine.
With an increasing ageing population, both the incidence and prevalence of osteoporotic VCFs are definitely on the rise. We are seeing many more patients suffering from this painful and debilitating condition when left untreated. It is our opinion that we are treating less than 10% of osteoporotic VCFs.
We have used BKP for the last 4 years at Guy's & St Thomas' and The London Bridge Hospitals, and our experience resoundingly confirms and concurs with the clinical safety and outcomes of the FREE study. Therefore, BKP should now be considered a standard of care in the treatment of painful osteoporotic VCFs and I sincerely hope that many more patients will continue to benefit from this form of minimally invasive surgery.
Let us know if you'd like to contact Khai Lam about a spinal problem.
