Degenerative Disc Disease
Conditions
Keywords
degenerative spine disease
Brief summary
Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. Carbon also allows for better visualization of the implants on MRI/CT and X-ray. There are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies. 118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.
Interventions
PROCEDURETitanium
Spinal stabilization using titanium screws and rods
PROCEDURECarbofix
Spinal stabilization using CarboFix screws and rods
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels; * Age greater than or equal to 18 years; * Ability to understand and sign the informed consent to the study and to follow the required follow-ups.
Exclusion criteria
* Metabolic bone disease. * History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, Ehlers-Danlos syndrome, osteogenesis imperfecta, achondroplasia. * Neoplastic disease. * History of mental disorder or current psychiatric treatment. * Pregnancy. * Immunodeficiency diseases. * Infectious bone disease (discitis, osteomyelitis) * Treatment with drugs that can interfere with bone metabolism * Inability to understand and sign the informed consent to the study and to follow the required follow-up visits. * Alcohol and/or drug abuse * Obesity * Metal allergy * Participation in other studies on drugs or devices (within 30 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion rate | through study completion, an average of 1 year | Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Classification system of surgical complications specific for spine | at baseline (day 0) | rate of intra-operative complications evaluated by SAVES classification system specific for spine |
| Visual Analogue Scale | at baseline (day 0) | A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. |
| Oswestry Disability Index | at baseline (day 0) | The Oswestry Disability Index (ODI) is a self-administered and validated questionnaire in Italian which aims to evaluate disabilities in subjects suffering from low back pain in both the acute and chronic phases. |
| EuroQoL-5D | at baseline (day 0) | EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition |
| Short Form-12 | at baseline (day 0) | The SF-12 is composed of 12 items (derived from the 36 of the original SF-36 questionnaire) which produce two measures relating to two different aspects of health: physical health and mental health. The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health). |
Countries
Italy
Contacts
CONTACTAlessandro Gasbarrini, MD
CONTACTCristiana Griffoni, PhD
Outcome results
None listed