Results from the first prospective clinical study evaluating the safety and efficacy of Cerapedics’ i-Factor bone graft in anterior lumbar interbody fusion (ALIF) procedures have been published in the peer-reviewed Journal of Neurosurgery: Spine. They indicate that the use of i-Factor improves outcomes.
Findings from the study, entitled “Clinical outcomes and fusion rates following ALIF with bone graft substitute i-Factor—an ABM/P-15 composite,” were presented by the research team led by Ralph J Mobbs (Prince of Wales Hospital in Australia).
In the non-blinded study, a total of 110 patients were treated with i-FACTOR biologic bone graft and evaluated for fusion rates and clinical outcomes with a mean follow-up of two years. According to a press release, treatment was shown to provide favourable clinical outcomes in patients who undergo ALIF surgery for degenerative spinal conditions by facilitating successful fusion of two or more vertebrae, also known as arthrodesis.
Fusion rate was assessed using fine cut coronal CT scans. In total, 94% of patients achieved arthrodesis. The one-level fusion rate was 98% (78/80), the two-level fusion rate was 82% (22/27), and the three-level fusion rate was 100% (3/3). While the mean follow-up time for collection of radiological data was 24 months, evidence of fusion was demonstrated as early as three to six months post-surgery in some patients (43% of one-level, 44% of 2-level).
The press release also reports that results also showed a statistically significant improvement between preoperative and postoperative scores when assessing patients using the Oswestry Low Back Pain Disability Questionnaire (ODI), Short Form-12, Odom’s criteria score, and a visual analogue scale for pain (VAS).
“Grafting supports bone regeneration in a variety of cases in orthopedic surgery, but harvesting autologous bone graft has been associated with a number of complications including chronic pain, infection, and fracture,” says Mobbs. “The use of orthobiologic materials that can deliver high fusion rates without the need to harvest autologous bone graft will represent a significant advance in patient care, and so these results involving treatment with i-Factor biologic bone graft are especially encouraging.”