A randomized controlled trial presented at the Annual Global Spine Congress in Singapore demonstrated that i-Factor was significantly superior to allografted bone for the enhancement of intertransverse fusion in patients who underwent spinal fusion surgery.
Mikkel O. Andersen
"There are many challenges when performing non-instrumented spinal fusion surgery in elderly patients including mechanical instability, and poor bone healing potential in this population,” Mikkel O. Andersen, MD, told Healio.com/Orthopedics. “Results from the IVANOS study indicate that i-Factor bone graft [Cerapedics] in combination with local harvested bone can address these challenges with significant higher fusion rates in patients compared to patients treated with bone bank allograft.”
Anderson and colleagues identified 98 patients with lumbar spinal stenosis or concomitant degenerative listhesis seen on MRI and lateral standing radiographs. Patients had received a minimum of 3 months of conservative therapy that had little or no effect. Investigators then randomly assigned 49 patients to receive i-Factor peptide enhanced bone graft and 49 patients to receive allograft bone, which were both combined with local lamina autograft from decompression. All patients underwent evaluation 1-year postoperatively.
Results showed 14 patients who received i-Factor had two-level fusion, whereas eight patients who received allograft had two-level fusion, with a total of 126 and 114 intertransverse segments left for evaluation, respectively. The intertransverse segmental fusion rate in patients who received i-Factor was 50% and 20.2% in patients who received allograft. The fusion rates in one-level listhesis patients who received i-Factor and allograft were 40.28% and 21.25%. In two-level patients who received i-factor and allograft, the fusion rates were 62.96% and 17.64%, respectively. - by Monica Jaramillo
Andersen MO, et al. I-factor versus allograft in non-instrumented lumbar fusion surgery. Presented at: Annual Global Spine Congress; May 2-5, 2018; Singapore.