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Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CAULE
León, Spain
Start Date
March 1, 2021
Primary Completion Date
March 1, 2024
Completion Date
March 1, 2027
Last Updated
February 9, 2021
128
ESTIMATED participants
i-FactorTM Bone graft
BIOLOGICAL
Lead Sponsor
Complejo Asistencial Universitario de León Urgencias
NCT04812730
NCT07434505
NCT04885244
Data Source & Attribution
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