Prospective i-FactorTM Analysis Fusion Rate and Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorComplejo Asistencial Universitario de León Urgencias
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
i-FactorTM Bone graft
Biological/VaccineIn 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: i-FactorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fusion rate
The success of the fusion at 12 and 24 months will be determined by a specialized radiologist by the evidence in the CT scan of trabecular bone bridges between the inter-transverse areas of the vertebral bodies and the absence of radiolucency adjacent to the implants.
Time frame
2 years2
Minimal Clinically Important Difference (MCID)
Minimal clinically important difference is defined a smallest clinical change that is important to the patient.
Time frame
2 years3
Short Form Health Survey-12 General Quality of life questionnaire
The questions that follow ask what you think about your health. Your answers will allow you to know how you are and to what extent you are able to do your usual activities. Patients improve when the puntuation is more than 50.
Time frame
2 years4
Owestry disability index
Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: