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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT04057235
Eligibility Criteria:
Inclusion Criteria:
To be a part of this study, the subject must:
1. Have been at least 18 years of age and skeletally mature at the time of surgery
2. Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine
3. Have been treated with PLIF or TLIF surgery using the FlareHawk expandable interbody cage(s) at 1 or 2 contiguous levels from L2 to S1
4. Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018
Exclusion Criteria:
Subjects must not meet any of the following exclusion criteria to be included in the study:
1. Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
2. Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
3. Have had surgery with the FlareHawk device(s) at more than 2 levels
4. Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1
5. Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space
6. Have any contraindications listed in the approved labeling
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04057235
Study Brief:
Protocol Section:
NCT04057235