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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03404232
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Legal capacity
* Age ≥ 18 years
* Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III or spondylolisthesis Meyerding grades I-III.
* Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability
Exclusion Criteria:
* Motor deficit
* Cauda equina syndrome
* Previous surgical intervention of the lumbar spine
* Relevant peripheral neuropathy
* Acute denervation subsequent to a radiculopathy
* Scoliosis with Cobb angle greater than 25°
* Spondylolisthesis \> Meyerding grade III
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
* No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with \>Fujiwara grade II or \>Pfirrmann grade IV
* Signs of instability in any lumbar spine segment other than that undergoing fusion
* General contraindication for elective lumbar spine surgery
* Pathologic fracture
* Osteoporosis with pathologic fracture
* Active systemic infection
* Rheumatic disease
* Disease of bone metabolism (e.g. Paget's Disease)
* Bone metastasis
* Local infection focus lumbar spine
* Seizure disorder
* Chronic ischemia Fontaine classification IIb-IV
* Severe heart insufficiency (NYHA III-IV)
* Blood coagulation disorder or blood thinning therapy
* Cortisone intake more than one month in the last 12 months before randomization
* Simultaneous participation in another clinical trial in the 30 days before randomization
* Known allergy or intolerance to the implants
* Dependency on investigator
* Lack of familiarity with the German language
* Placement in an institution by governmental or juridical advice
* Absent legal capacity
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03404232
Study Brief:
Protocol Section:
NCT03404232