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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT04017468
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age requiring open instrumented dorsal spinal fusion of at least 1 level (involving two adjacent vertebras and one intervertebral disc)
* Signed informed consent
Exclusion Criteria:
* Preoperative ongoing infectious disease present as judged by primary surgeon (based on lab results and clinical assessment);
* Previous spine surgery at index level within last 90 days;
* Known allergy to vancomycin;
* Percutaneous or transmuscular instrumentation (minimally-invasive surgery) only without lumbar interbody fusion;
* Postoperative radiotherapy of surgical site required (e.g. for tumor)
* Preexisting cochlea damage OR known history of hearing loss NOT clearly associated with age-related hearing impairment (presbycusis);
* Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse;
* Pregnancy or breastfeeding women;
* Participation in other ongoing clinical trials;
* Patients lacking capacity to consent;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04017468
Study Brief:
Protocol Section:
NCT04017468