NCT04610021

Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Complejo Asistencial Universitario de León Urgencias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Spinal Deformity
• Bone Graft
• Fusion Rate
• Quality of Life

Interventions

Type	Name	Description
BIOLOGICAL	i-FactorTM Bone graft	In the i-Factor ™ group it will be placed longitudinally in the intertransverse area. Likewise, in both groups, only autologous and bench bone will be placed in the intersomatic cages. The vertebrae where the i-Factor ™ is placed will be noted on the data collection sheet.

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-03-01
• Completion: 2027-03-01
• First posted: 2020-10-30
• Last updated: 2021-02-09

Locations

1 site across 1 country: Spain