Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-23

Study Completion Date

2019-12-18

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.

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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.

Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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FlareHawk Interbody Fusion System

Expandable lumbar intervertebral body fusion device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

To be a part of this study, the subject must:

1. Have been at least 18 years of age and skeletally mature at the time of surgery
2. Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine
3. 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
4. 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

1. Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
2. Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
3. Have had surgery with the FlareHawk device(s) at more than 2 levels
4. Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1
5. Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space
6. Have any contraindications listed in the approved labeling

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes