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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT05538416
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years
* Degenerative or spondylolytic spondylolisthesis
* Neurogenic claudication and/or radicular leg pain
* Low grade (Meyerding grade l and ll)
* Persistent complaints for over 3 months
Exclusion Criteria:
* Previous spine fusion surgery at the same level
* Osteoporosis
* Active infection or prior infection at the surgical site
* Active cancer
* Spondylolisthesis grade lll or greater
* More than one symptomatic level that needs fusion
* Pregnancy
* Contraindication for surgery
* Severe mental or psychiatric disorder
* Substance abuse
* Inadequate knowledge of Dutch language
* Morbid obesity (body mass index \>40)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05538416
Study Brief:
Protocol Section:
NCT05538416