The clinical outcomes demonstrated a statistically significant (p < 0.05) difference between preoperative and postoperative Oswestry Disability Index, 12-Item Short Form Health Survey, and visual analog scores. At a mean of 24 months of follow-up (range 15-43 months), 97.5%, 81%, and 100% of patients, respectively, who had undergone single-, double-, and triple-level surgery exhibited fusion at all treated levels. Fine-cut CT scans were used to evaluate the progression to fusion.Īll patients who received i-FACTOR demonstrated radiographic evidence of bony induction and early incorporation of bone graft. Patient's clinical outcomes were assessed using the Oswestry Disability Index for low-back pain, the 12-Item Short Form Health Survey, Odom's criteria, and a visual analog scale for pain. One hundred ten patients with degenerative spinal disease underwent single or multilevel ALIF using the ABM/P-15 bone graft composite with a mean of 24 months (minimum 15 months) of follow-up were enrolled in the study. The authors' goal was to determine the safety and efficacy of i-FACTOR bone graft composite used in patients who underwent ALIF by evaluating fusion rates and clinical outcomes.Ī nonblinded cohort of patients who were all referred to a single surgeon's practice was prospectively studied. Although preclinical studies have documented its usefulness, the role of i-FACTOR in ALIF procedures remains unknown. In particular, i-FACTOR, a novel bone graft substitute composed of anorganic bone matrix (ABM) with P-15 small peptide, is one example currently used widely in the dental community. The search for alternative grafts yielding comparable or superior fusion outcomes with fewer complications continues. Recently, a second Level 1 investigational device exemption (IDE) study was initiated for use in transforaminal lumbar interbody fusion.Despite limited availability and the morbidity associated with autologous iliac crest bone graft (ICBG), its use in anterior lumbar interbody fusion (ALIF) procedures remains the gold standard to achieve arthrodesis. i-FACTOR is also supported by three additional published peer-reviewed clinical studies from international usage. These results were used to support FDA approval of i-FACTOR in this indication. For example, study results published in the peer-reviewed journal Spine involving 319 patients who underwent anterior cervical discectomy and fusion surgery showed that i-FACTOR was superior to autograft in composite overall success one-year post-surgery.

How does this product benefit the surgical team and aid in better outcomes?Ĭompleted clinical research indicates that i-FACTOR is statistically superior to autograft in overall patient success. While these products are commonly used by surgeons, the P-15 technology is supported by Level 1 human clinical data and has the potential to offer a safe, effective and economical alternative that surgeons need and that aligns with the values of healthcare systems. Other alternatives include bone morphogenetic proteins (BMPs), demineralized bone matrix (DBM), and stem cell therapies. This approach presents risks such as infection, nerve damage, bleeding, and chronic pain around the graft site. Historically, the gold standard was using a bone graft obtained from the patient’s pelvis to promote fusion (autograft). While you may already know that smiles need strong teeth to remain functional and beautiful, did you know that without healthy gums, lasting oral health isnt. What sets this product apart from others available in the industry?

Ifactor health