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:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT00432159
Eligibility Criteria:
Key Inclusion Criteria:
* Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
* Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
* Moderate Neck Disability Index (NDI) score
* Able to give informed consent for study participation
* Able and willing to return for all follow-up visits
Key Exclusion Criteria:
* Significant cervical degenerative disc disease
* Prior fusion procedure at any level(s) (C1-T1)
* Marked cervical instability on lateral or flexion/extension radiographs
* Presence of systemic infection or infection at the surgical site
* Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
* History of alcohol and/or drug abuse
* Any known allergy to a metal alloy or polyethylene
* Morbid obesity
* Any significant general illness (e.g., metastatic cancer, HIV)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00432159
Study Brief:
Protocol Section:
NCT00432159