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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01406405
Eligibility Criteria:
Lumbar Fusion Patient Group
Inclusion Criteria:
* Skeletally mature adults between 18 and 70 years old
* Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
* Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
* Willing and able to comply with the requirements of the protocol including followup requirements
* Willing and able to sign a study specific informed consent.
Exclusion Criteria:
* More than 3 intervertebral levels to be fused
* Posterior fixation used at more than 1 level for 1-level intervertebral fusion
* Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
* Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
* Any additional approaches, e.g. anterior, XLIF
* Active local or systemic infection
* Prior interbody fusion surgery at the index level
* Prior fusion at the adjacent levels
* Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
Cervical Fusion Patient Group
Inclusion Criteria:
* Skeletally mature adults between 18 and 70 years old
* Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels
* Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
* Willing and able to comply with the requirements of the protocol including followup requirements
* Willing and able to sign a study specific informed consent
Exclusion Criteria:
* More than 3 vertebral levels to be fused
* Any additional approaches, e.g. posterior cervical fusion
* Active local or systemic infection
* Prior interbody fusion surgery at the index level
* Prior fusion at the adjacent level
* Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01406405
Study Brief:
Protocol Section:
NCT01406405