Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Adult spinal deformity surgery is a complex procedure that involves many risks and complications. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery. Autologous bone has been considered the "gold-standard" for obtaining a spinal fusion. However, the source from which to obtain it is limited. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options. I-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles. In the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending

NCT Number	NCT04610021
Lead Sponsor	Complejo Asistencial Universitario de León Urgencias
Conditions	Spinal Deformity, Bone Graft, Fusion Rate, Quality of Life
Enrollment	128 participants
Start Date	2021-03
Primary Completion	2024-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2021-02-09