Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Completed
Conditions studied: Degenerative Disc Disease
In brief
This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion cage at one or two contiguous levels.
Key facts
- Study ID
- NCT04057235
- Run by
- Integrity Implants Inc.
- People needed
- 129
- Starts
- 2019-09-23
- Expected to finish
- 2019-12-18
- Last updated by the study team
- 2020-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- To be a part of this study, the subject must:
- Have been at least 18 years of age and skeletally mature at the time of surgery
- Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine
- 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
- Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018
You may not qualify if…
- Subjects must not meet any of the following exclusion criteria to be included in the study:
- Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
- Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
- Have had surgery with the FlareHawk device(s) at more than 2 levels
- Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1
- Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space
- Have any contraindications listed in the approved labeling
Where it is running
- Chatham Orthopaedic Associates — Savannah, Georgia, United States
- Carolina Neurosurgery & Spine Associates — Charlotte, North Carolina, United States
- Northeast Ohio Spine Center — Akron, Ohio, United States
Full record on ClinicalTrials.gov
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