Promising results found for biphasic calcium-phosphate as a bone graft substitute in spine fusion
Click Here to Manage Email Alerts
Use of biphasic calcium-phosphate was a successful substitute as a standalone bone graft for autograft in instrumented posterolateral fusion of the thoracolumbar spine, according the results of a non-inferiority trial.
A. Mechteld Lehr, MSc, and colleagues at the Dutch Clinical Spine Research Group tested the efficacy of NuVasive’s AttraX Putty, a material with limited clinical evidence, the authors wrote.
For the 100 patients tested (49 men and 51 women, mean age of 55.4±12 years), the microporous synthetic ceramic was placed on a randomized side, with autograft applied to the contralateral side of the fusion trajectory, according to the abstract. This way, each patient could serve as his/her own control.
At 1-year follow-up, posterolateral fusion (PLF) was assessed and scored as either “fused, doubtful fusion or non-union,” the researchers wrote. “After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a non-inferiority margin of 15% using a 90% confidence interval (CI).”
Resulting data from the primary analysis indicated positive results for the biphasic calcium-phosphate substitute in instrumented PLF.
“The fusion rate of AttraX Putty was 55% vs. 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the non-inferiority margin (difference=2.3%, 90% CI=-9.1% to +13.7%),” according to the study. – by Max R. Wursta
Disclosures: The authors reported that they received funds from NuVasive Inc. in support of this work and received grants outside the submitted work.
Read more about
Click Here to Manage Email Alerts