Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedure with a FlareHawk expandable interbody fusion cage(s) to assess the device's performance and safety when used in accordance with its intended use. The primary hypothesis is that study subjects who received the FlareHawk expandable cage(s) through a TLIF or PLIF procedure experienced fusion by 12 months (+/- 3 mo) follow-up, with improvements in clinical outcomes related to pain and/or disability compared to pre-operative scores. Further, the subjects are hypothesized to have not experienced any unforeseen device- or procedure-related adverse events.

Official Title
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Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: FlareHawk Interbody Fusion System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FlareHawk Interbody Fusion System|Expandable lumbar intervertebral body fusion device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Arthrodesis | Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system [Bridwell and Lenke et al, 1995]. | 12 months +/- 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up | Visual analog scale for measuring pain intensity related to leg pain. The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). | From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo) | 
| Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up | Visual analog scale for measuring pain intensity related to back pain. The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). | From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo) | 
| Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up | ODI is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. | From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo) |