N/A
N=129
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Degenerative Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT04057235 ↗Enrolled (actual)
129
Serious AEs
2.3%
Results posted
Apr 2020
Primary outcome: Primary: Radiographic Arthrodesis — 56 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- FlareHawk Interbody Fusion System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Integrity Implants Inc.
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Arthrodesis |
56 | — |
| SECONDARY Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up |
-3.9 | — |
| SECONDARY Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up |
-3.4 | — |
| SECONDARY Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up |
-14.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT04057235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.