Louis A. Gilula MD, Presenter: Researcher, Orthovita, Inc

To examine if and how vertebroplasty affects health-related quality of life and to compare results between two different vertebral augmentation implant materials. Repeated Quality of Life measures collected over a two year period were used to evaluate physical and mental functioning in osteoporotic patients undergoing vertebroplasty. Two sham studies in osteoporotic VCF patients concluded clinical improvement was similar between vertebroplasty and sham. 

In a prospective randomized controlled study, 256 patients with osteoporotic Vertebral Compression Fractures (VCFs) were treated with vertebroplasty using either a bioactive bone augmentation material Cortoss (n=162), or PMMA bone cement (n=94). The Short Form-12 Health Survey is a Quality of Life measure that yields two scores: Physical Component Score (PCS) and Mental Component Score (MCS). The SF-12 was completed by patients at baseline and at 1, 3, 6, 12 and 24-months post-vertebroplasty.

When interpreting SF–12 scores, a higher score means improved or better functioning. At baseline, study participant scores were nearly identical between groups and were lower (worse) than average scores for an age-matched general population. Over time, in both study groups, MCS and PCS scores improved from baseline. Response rates between groups were comparable, with the exception of two PCS domains; General Health score at 12 months and Physical Functioning score at 24 months, where Cortoss patients did significantly better than the PMMA patients (p<0.05). The mean improvement in PCS for Cortoss patients was consistently 1 to 2 points higher than PMMA patients; there was no observable trend for the MCS at 24 months.

At 24-months post-vertebroplasty, the final PCS and MCS scores in both study groups closely approached the average scores for an age-matched general population without VCFs. The type of material used influenced general health and physical functioning scores at different timepoints. This study demonstrates that vertebroplasty does improve the health-related quality of life in osteoporotic patients who have experienced a VCF.

At six-month followup, this study shows that vertebroplasty patients experienced an improved quality of life at 2 year followup. 

Gilula, L, Does Vertebroplasty Improve Health-related Quality of Life?.  Radiological Society of North America 2010 Scientific Assembly and Annual Meeting, November 28 - December 3, 2010 ,Chicago IL. http://archive.rsna.org/2010/9008421.html