i-FACTOR Bone Graft is ready to use and thus requires no mixing or other preparation prior to use. Study design: A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial.

I-FACTOR Bone Graft products are sterilized after packaging (terminally sterilized), can be stored at room temperature and have a three-year shelf life. The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation. i-FACTOR Putty i-FACTOR Bone Graft is an advanced biologic that is supported with level I evidence, satisfies the highest regulatory imperatives, and provides a better cost/benefit ratio than engineered growth factors and cellular allografts.

I-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR peptide enhanced bone graft had a 30 higher fusion rate than allograft in patients with non-instrumented surgery. Michael Kjær Jacobsen, at the Center for Spine Surgery and Research in Southern Denmark, led the double-blind, prospective, randomized study in more than 100 patients (60 years or older.

Ifactor surgery