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NCT Number: 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

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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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Alessandro Gasbarrini, MD

CONTACT

[email protected]

Alessandro Gasbarrini, MD

PRINCIPAL_INVESTIGATOR

Cristiana Griffoni, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Titanium

Procedure

Spinal stabilization using titanium screws and rods

Carbofix

Procedure

Spinal stabilization using CarboFix screws and rods

Primary outcomes

  1. Fusion rate

    Time frame: 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 outcomes

  1. Classification system of surgical complications specific for spine

    Time frame: at baseline (day 0)

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

  2. Classification system of surgical complications specific for spine

    Time frame: up to 12 months

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

  3. Visual Analogue Scale

    Time frame: 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.

  4. Visual Analogue Scale

    Time frame: after 12 months

    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.

  5. Visual Analogue Scale

    Time frame: after 3 months

    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.

  6. Visual Analogue Scale

    Time frame: after 6 months

    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.

  7. Oswestry Disability Index

    Time frame: 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.

  8. Oswestry Disability Index

    Time frame: after 12 months

    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.

  9. Oswestry Disability Index

    Time frame: after 3 months

    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.

  10. Oswestry Disability Index

    Time frame: after 6 months

    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.

  11. EuroQoL-5D

    Time frame: 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

  12. EuroQoL-5D

    Time frame: after 12 months

    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

  13. EuroQoL-5D

    Time frame: after 3 months

    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

  14. EuroQoL-5D

    Time frame: after 6 months

    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

  15. Short Form-12

    Time frame: 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).

  16. Short Form-12

    Time frame: after 12 months

    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).

  17. Short Form-12

    Time frame: after 3 months

    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).

  18. Short Form-12

    Time frame: after 6 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Gasbarrini, MD

CONTACT

[email protected]

0516366 ext. 130

Cristiana Griffoni, PhD

CONTACT

[email protected]

0516366 ext. 130

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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