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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT01549366
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years
* Scheduled for an elective single-level circumferential lumbar fusion by means of supplemental posterior fusion with fixation (allowing for the placement of ASPEN or pedicle screws) for an anterior or lateral interbody fusion
* Diagnosis of primary symptomatic Degenerative Disc Disease (DDD) and/or spondylolisthesis confirmed with appropriate imaging studies and/or positive lumbar discography
* Oswestry Disability Index (ODI) v2.1 score \> 30%
* Failed at least 3 months of conservative care (non-surgical) OR has clinical signs of neurological deterioration
* Signed Informed Consent Form
Exclusion Criteria:
* Previous fusion at the operative level
* Spondylolisthesis Grade 3 or more
* Lytic spondylolisthesis
* Incompetent or missing posterior arch at the affected level (e.g. complete laminectomy, pars defect)
* Requires complete laminectomy at level of surgery
* Facet joints at implant level are absent or fractured
* Vertebral body compromise or acute fracture at implant level
* Body mass Index (BMI) ≥ 35
* Known allergy to titanium
* Osteoporosis: Simple Calculated Osteoporosis Risk Estimation (S.C.O.R.E.) \> 6 AND Dual-energy X-ray absorptiometry (DEXA) T-score \< -2.5
* Paget's disease, osteomalacia, or any other metabolic bone disease
* Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
* Planned use of additional segmental fixation (eg. facet screws)
* Planned use of Bone Morphogenetic Protein (BMP) for posterolateral fusion\*
* Unlikely to comply with the follow-up evaluation schedule
* In the opinion of the Investigator, Subject has history of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
* Active participation in a clinical trial of another drug or device
* Active systemic infection or any other health condition that would preclude surgery
* History of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
* Subject is a prisoner
* Pregnant or planning to become pregnant during the length of study participation
* Involvement in active litigation related to back problems at the time of screening
* Direct involvement in the execution of this protocol
* Pre-existing conditions that could interfere with the evaluation of outcome measures (e.g. musculoskeletal, neuromuscular, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01549366
Study Brief:
Protocol Section:
NCT01549366