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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group: autologous bone + bench bone | |
| i-Factor | Experimental | I-Factor group: autologous bone + bench bone + i-Factor™ bone graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-FactorTM Bone graft | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Minimal Clinically Important Difference (MCID) | Minimal clinically important difference is defined a smallest clinical change that is important to the patient. | 2 years |
| 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. | 2 years |
| Owestry disability index | Disability index questionnaire Maximun value=100 Minimun value=0 Patients improve when this index is arround 0 | 2 years |
| VISUAL ANALOGUE SCALE | Is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Maximun value=10 Minimun value=0 Patients improve when this index is arround 0 | 2 years |
| Scoliosis Research Society (SRS-22) | Scoliosis reseach society questionnaire 22 questions 5 options Dimensions Pain Function Selfimage Mental Health Satrisfaction Puntuation for item and test: 1(worse) - 5(better) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAULE | León | Spain |
|
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prospective randomized with intervention study.
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| 2 years |