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i-FACTOR bone graft material demonstrates equal or greater efficacy vs. autograft for PLIF
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In a 2-year study examining the use of i-FACTOR bone graft material in posterior lumbar interbody fusion, researchers found the alternative material had equal or greater efficacy at 6 and 12 months compared with autograft.
The prospective, clinical and radiological study included 40 patients who underwent posterior lumbar interbody fusion (PLIF) surgery, with each patient serving as his or her own control. Each patient received two paired cages — one inside which local autograft bone was placed, and the other inside which i-FACTOR (ABM/P-15, Cerapedics) bone graft was placed — for each vertebral level being treated.
Primary success criteria were based on fusion and safety, with assessments taken for up to 24 months, including radiographs, CT scan, VAS and Oswestry Disability Index scores.
The researchers observed a statistically significantly earlier occurrence of intra-cage bridging bone with ABM/P-15 in 97.73% of patients at 6 months, compared with 59.09% in the autograft cohort. At 12 months, fusion rates were 97.78% vs. 82.22% for ABM/P-15 and autograft, respectively.
Overall, pain decreased by 29 points, on average, and function improved by 43 points, according to the researchers.
The researchers concluded that radio dense material outside the disk space occurred more frequently with ABM/P-15 than autograft, without clinical consequence. Additionally, functional improvement exceeded success criteria at all time points. – by Robert Linnehan
Disclosure: The study was supported via a grant from Cerapedics.
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