Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Complejo Asistencial Universitario de León Urgencias

Status

Not yet enrolling

Conditions

Fusion Rate

Quality of Life

Spinal Deformity

Bone Graft

Treatments

Biological: i-FactorTM Bone graft

Study type

Interventional

Funder types

Other

Identifiers

NCT04610021

CAULE-IFACTOR

Details and patient eligibility

About

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

Enrollment

128 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of legal age.
Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs.
Patients who provide their informed consent in writing. (In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative).
Present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery.
The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.

Exclusion criteria

Patients who are expected to be unavailable for follow-up.
Patients with mental disabilities that make it difficult for them to fill in the questionnaires.
Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.
Patients who are going to have cemented and / or expansive screws, Peek boxes or another type of material other than Titanium.
Underlying neurological or neuromuscular disease.
Underlying inflammatory or tumor disease.