The Center for Spine and Orthopedic’s own Dr. Michael Janssen recently co-authored a study that was published in SPINE! Check out a portion of the abstract, below.
Study Design: Prospective, randomized, controlled, parallel, single-blinded non-inferiority multi-center pivotal FDA IDE trial.
Objective: To investigate efficacy and safety of i-Factor(TM) Bone Graft (i-Factor) compared to local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy.
Summary of Background Data: i-Factor is a composite bone substitute material consisting of the P-15(TM) synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15(TM) has demonstrated bone healing efficacy in dental, orthopedic, and non-human applications.
Methods: Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as non-inferiority in fusion, Neck Disability Index (NDI) and Neurological Success endpoints, and similar adverse events profile at 12 months.