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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01972256
Eligibility Criteria:
Inclusion Criteria:
* Adult 18 years of age or older
* Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)
* Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons
* Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery
Exclusion Criteria:
* Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1
* Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01972256
Study Brief:
Protocol Section:
NCT01972256