Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Integrity Implants Inc.
- Enrollment
- 129
- Locations
- 3
- Primary Endpoint
- Radiographic Arthrodesis
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
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
Outcomes
Primary Outcomes
Radiographic Arthrodesis
Time Frame: 12 months +/- 3 months
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 \[Bridwell and Lenke et al, 1995\].
Secondary Outcomes
- Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up(From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo))
- Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up(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(From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo))