Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

NCT ID: NCT04610021

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2027-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Control group: autologous bone + bench bone

Group Type: NO_INTERVENTION

No interventions assigned to this group

i-Factor

I-Factor group: autologous bone + bench bone + i-Factor™ bone graft

Group Type: EXPERIMENTAL

i-FactorTM Bone graft

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Complejo Asistencial Universitario de León Urgencias

OTHER

Sponsor Role: lead

Responsible Party

Manuel Fernández González

Jefe de Servicio

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CAULE

León, , Spain

Countries

Spain

Facility Contacts

Manuel Fernandez Gonzalez

Role: primary

Other Identifiers

CAULE-IFACTOR

Identifier Type: -

Identifier Source: org_study_id