The savings proved to be incremental over time, increasing to 3.7% over an extrapolated 10 years. In all scenarios, i-FACTOR reduced costs within the first year by 1.4% to 2.1%. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio (ICER). Health-related utility outcome was expressed in quality-adjusted life years (QALYs). In the base-case analysis, both health and societal system costs were evaluated. Two primary outcome measures were assessed: cost and utility. We analyzed various real-world scenarios, including inpatient and outpatient surgical settings as well as private versus public insurances. Patients randomly received either autograft (N = 154) or i-Factor (N = 165). The patient cohort was extracted from a prospective, multicenter randomized control trial (RCT) from twenty-two North American centers. To evaluate the cost-effectiveness of i-FACTOR compared to autograft for patients undergoing ACDF surgery. Cost-effectiveness of these innovations remains an often-overlooked aspect of this effort. The efficacy and safety of traditional anterior cervical discectomy and fusion (ACDF) surgery has improved with the introduction of new implants and compounds. We conducted decision analytical modeling using a Markov model to determine the ICER of i-factor compared to autograft in ACDF surgery. Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery. There were no allergic reactions associated with i-Factor™. Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation ( P =. The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P =. 4507), and SF36v2 Mental Component Score improved 7.88 (i-Factor TM ) and 7.53 (autograft P =. 1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft P =. 2763) Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft P =. 1448) Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p =. Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft P =. 2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft P =. Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes.Īt 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively ( P =. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. I-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier.
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