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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT02294669
Eligibility Criteria:
Inclusion Criteria:
* one-level fusion at L4/L5 with dorsal instrumentation and, if required, with monolateral decompression and/or intervertebral disc removal and implantation of an intervertebral implant
Exclusion Criteria:
Patient
* had previous surgical stabilizations at the involved or adjacent levels
* has lytic spondylolisthesis
* has degenerative spondylolisthesis grade II or higher
* has radiographic signs of significant instability and/or hypermobility of the segment (\>3mm translation, \>11° rotation difference from adjacent level)
* has scoliosis \> 10° at the involved segment
* has osteoporosis to a degree that spinal instrumentation would be contraindicated.
* has presence of active malignancy.
* has overt or active infection, either local or systemic
* is less than 18 years old
* is pregnant or plan a pregnancy during the study duration
* has a BMI \> 35
* has a progressive neuromuscular disease
* has a condition which requires postoperative medications that may interfere with bone metabolism
* has a history of autoimmune disease
* has a history of endocrine or metabolic disorders known to affect osteogenesis
* is mentally ill or incompetent
* is an alcohol and/or drug abuser
* is not available for follow up visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02294669
Study Brief:
Protocol Section:
NCT02294669