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Integrity Implants FlareHawk® Study

2019-08-18 20:09:27 | BioPortfolio

Summary

This is a retrospective clinical study (chart review) of patients who have previously undergone TLIF or PLIF surgery with the FlareHawk expandable interbody fusion cage at one or two contiguous levels.

Description

The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a TLIF or 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.

Study Design

Conditions

Degenerative Disc Disease

Intervention

FlareHawk Interbody Fusion System

Status

Not yet recruiting

Source

Integrity Implants Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-18T20:09:27-0400

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Medical and Biotech [MESH] Definitions

Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.

The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.

Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.

A degenerative disease of the AUTONOMIC NERVOUS SYSTEM that is characterized by idiopathic ORTHOSTATIC HYPOTENSION and a greatly reduced level of CATECHOLAMINES. No other neurological deficits are present.

An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.

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