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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Titanium

    Procedure/Surgery

    Spinal stabilization using titanium screws and rods

  • Carbofix

    Procedure/Surgery

    Spinal stabilization using CarboFix screws and rods

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: TraditionalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fusion rate

Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Classification system of surgical complications specific for spine

rate of intra-operative complications evaluated by SAVES classification system specific for spine

Time frame
at baseline (day 0)
2

Classification system of surgical complications specific for spine

rate of post-operative complications evaluated by SAVES classification system specific for spine

Time frame
up to 12 months
3

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.

Time frame
at baseline (day 0)
4

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.

Time frame
after 12 months

Other outcomes

Sponsors and contacts

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