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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | CarboFix implant for spinal surgery |
|
| Traditional | Active Comparator | Titanium implant for spinal surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium | Procedure | Spinal stabilization using titanium screws and rods |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rate | Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Classification system of surgical complications specific for spine | rate of intra-operative complications evaluated by SAVES classification system specific for spine | at baseline (day 0) |
| Classification system of surgical complications specific for spine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Gasbarrini, MD | Contact | 0516366 | 130 | alessandro.gasbarrini@ior.it |
| Cristiana Griffoni, PhD | Contact | 0516366 | 130 | cristiana.griffoni@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28815357 | Background | Boriani S, Tedesco G, Ming L, Ghermandi R, Amichetti M, Fossati P, Krengli M, Mavilla L, Gasbarrini A. Carbon-fiber-reinforced PEEK fixation system in the treatment of spine tumors: a preliminary report. Eur Spine J. 2018 Apr;27(4):874-881. doi: 10.1007/s00586-017-5258-5. Epub 2017 Aug 16. | |
| 32691220 | Background |
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| Carbofix |
| Procedure |
Spinal stabilization using CarboFix screws and rods |
|
rate of post-operative complications evaluated by SAVES classification system specific for spine |
| up to 12 months |
| Visual Analogue Scale | 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. | at baseline (day 0) |
| Visual Analogue Scale | 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. | after 12 months |
| Visual Analogue Scale | 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. | after 3 months |
| Visual Analogue Scale | 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. | after 6 months |
| Oswestry Disability Index | 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. | at baseline (day 0) |
| Oswestry Disability Index | 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. | after 12 months |
| Oswestry Disability Index | 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. | after 3 months |
| Oswestry Disability Index | 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. | after 6 months |
| EuroQoL-5D | 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 | at baseline (day 0) |
| EuroQoL-5D | 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 | after 12 months |
| EuroQoL-5D | 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 | after 3 months |
| EuroQoL-5D | 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 | after 6 months |
| Short Form-12 | 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). | at baseline (day 0) |
| Short Form-12 | 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). | after 12 months |
| Short Form-12 | 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). | after 3 months |
| Short Form-12 | 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). | after 6 months |
| Boriani S, Pipola V, Cecchinato R, Ghermandi R, Tedesco G, Fiore MR, Dionisi F, Gasbarrini A. Composite PEEK/carbon fiber rods in the treatment for bone tumors of the cervical spine: a case series. Eur Spine J. 2020 Dec;29(12):3229-3236. doi: 10.1007/s00586-020-06534-0. Epub 2020 Jul 20. |
| 10795032 | Result | Vaccaro AR, Garfin SR. Pedicle-Screw Fixation in the Lumbar Spine. J Am Acad Orthop Surg. 1995 Oct;3(5):263-274. doi: 10.5435/00124635-199509000-00002. |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014025 | Titanium |
| ID | Term |
|---|---|
| D019565 | Metals, Light |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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