Status:
COMPLETED
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Lead Sponsor:
Integrity Implants Inc.
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
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 e...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04057235
Start Date
September 23 2019
End Date
December 18 2019
Last Update
April 21 2020
Active Locations (3)
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1
Chatham Orthopaedic Associates
Savannah, Georgia, United States, 31405
2
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States, 28204
3
Northeast Ohio Spine Center
Akron, Ohio, United States, 44333