Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT04605120
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged ≥18 years old
2. Patient eligible for anterior cervical fusion combined with bone graft after failure of well-conducted medical treatment.
3. Arthrodesis performed on up to 2 levels and fused by one or more plates with an interbody cage on at least one level
4. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia, or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy
5. X-ray diagnosis of cervical herniated disc and/or osteophyte at 1 or 2 levels depending on clinical signs and symptoms, disc degeneration, trauma without neurological damage
6. Ability and willingness to comply with project requirements
7. Written informed consent given by the subject or the subject's legally authorized representative
Exclusion Criteria:
1. Acute local or systemic infection
2. Women who are pregnant or in a desire to be pregnant or breast-feeding
3. Any contraindication to the proposed surgical procedure
4. Previous cervical surgery (either anterior or posterior)
5. Surgery performed over several operating times
6. Arthrodesis performed posteriorly or involving more than 2 levels or not requiring the use of a bone graft
7. Systemic disease, metabolic bone disease and autoimmune disease.
8. Use of any known drug to potentially interfere with the healing of bones and soft tissues (corticosteroids or immunosuppressive agents...)
9. Any other concomitant medical disease or treatment that could significantly alter the normal healing process as assessed by the investigator
10. Neoplasm of the spine
11. Severe mental or psychiatric disorders
12. Any other condition that, in the investigator's view, would adversely affect patient safety or would not meet the requirements of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04605120
Study Brief:
Protocol Section:
NCT04605120