NCT04057235

Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: Integrity Implants Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	FlareHawk Interbody Fusion System	Expandable lumbar intervertebral body fusion device

Timeline

• Start date: 2019-09-23
• Primary completion: 2019-12-13
• Completion: 2019-12-18
• First posted: 2019-08-15
• Last updated: 2020-04-21
• Results posted: 2020-04-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study