Clinical trial NCT06209684: Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases
Official title: Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: degenerative spine disease
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Fusion rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Classification system of surgical complications specific for spine
timeFrame: at baseline (day 0)
measure: Classification system of surgical complications specific for spine
timeFrame: up to 12 months
measure: Visual Analogue Scale
timeFrame: at baseline (day 0)
measure: Visual Analogue Scale
timeFrame: after 12 months
measure: Visual Analogue Scale
timeFrame: after 3 months
measure: Visual Analogue Scale
timeFrame: after 6 months
measure: Oswestry Disability Index
timeFrame: at baseline (day 0)
measure: Oswestry Disability Index
timeFrame: after 12 months
measure: Oswestry Disability Index
timeFrame: after 3 months
measure: Oswestry Disability Index
timeFrame: after 6 months
measure: EuroQoL-5D
timeFrame: at baseline (day 0)
measure: EuroQoL-5D
timeFrame: after 12 months
measure: EuroQoL-5D
timeFrame: after 3 months
measure: EuroQoL-5D
timeFrame: after 6 months
measure: Short Form-12
timeFrame: at baseline (day 0)
measure: Short Form-12
timeFrame: after 12 months
measure: Short Form-12
timeFrame: after 3 months
measure: Short Form-12
timeFrame: after 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.