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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01019057
Eligibility Criteria:
Inclusion Criteria:
* Patient is over 40 years of age;
* Patient is diagnosed with single-level lumbar degenerative disc disease between L1-L2 and L4-L5 with evidence of disc collapse and symptomatic claudication with or without back pain and requires surgical intervention;
* Patient is unresponsive to conservative treatment greater than or equal to six month 6 months, or exhibits progressive neurological symptoms in the face of conservative treatment;
* Patient is willing and able to comply with the requirements defined in the protocol for the duration of the study;
* Patient has signed and dated Informed Consent.
Exclusion Criteria:
* Patients with lumbar pathologies requiring surgical treatment at more than one level;
* Patients with spondylolisthesis \> grade 1;
* Patients with lytic spondylolisthesis or a defect of the pars interarticularis;
* Patients with prior lumbar surgery at or adjacent to the operative level;
* Patients with spinal metastases or active spinal tumor malignancy;
* Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis;
* Present chronic steroid use;
* Patients with rheumatoid arthritis or other autoimmune disease;
* Patients who are pregnant or interested in becoming pregnant within the follow-up period of the study;
* Patients with a history of substance abuse;
* Patients involved in active spinal litigation;
* Patients receiving workman's compensation for spinal conditions;
* Patients who are mentally incompetent;
* Patients who are incarcerated;
* Patients who are unwilling or unable to comply with the follow-up protocol schedule of visits and assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01019057
Study Brief:
Protocol Section:
NCT01019057