Prospective i-FactorTM Analysis Fusion Rate and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: i-FactorTM Bone graft.
- Who it may be relevant to
- Registry conditions: Spinal Deformity, Bone Graft, Fusion Rate, Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity
Overview
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
Interventions
- 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.
Primary outcome measures
- Fusion rate [Time frame: 2 years]
- Minimal Clinically Important Difference (MCID) [Time frame: 2 years]
- Short Form Health Survey-12 General Quality of life questionnaire [Time frame: 2 years]
- Owestry disability index [Time frame: 2 years]
- VISUAL ANALOGUE SCALE [Time frame: 2 years]
- Scoliosis Research Society (SRS-22) [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- CAULE — León
Identifiers
NCT: NCT04610021 · CAULE-IFACTOR