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Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease

2019-10-21 12:45:23 | BioPortfolio

Summary

This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion (extreme lateral interbody fusion (XLIF)). MagnetOs Putty will be used according to the instructions for use.

Description

In this study, following a screening period of maximum 30 days, 20 patients will undergo a single/two-level XLIF procedure and will receive MagnetOs Putty at the diseased level(s). They will be followed up at discharge, Week 6, Month 3, Month 6 and Month 12 post-surgery. The primary endpoint will be analyzed at Month 12.

In this study, MagnetOs Putty will be applied according to the latest Instructions For Use (IFU) approved in Europe. Specifically, MagnetOs Putty will be used as bone void filler alone (ideally 10 patients) or with autogenous/allogenous bone graft (ideally10 patients) based on patient's condition and investigator's decision. Autogenous bone graft may be harvested locally or from the iliac crest. In the context of filling of intervertebral implant (e.g. interbody cage), the choice of implant should be appropriate to enable successful fusion but will be left to the investigator discretion.

The extreme lateral interbody fusion surgical procedure will be left to the investigator discretion.

Radiographs will be taken at Screening, Day 0, Month 3 and 12, while CT-scans will only be taken at Month 6 and Month 12.

Study Design

Conditions

Degenerative Disc Disease

Intervention

MagnetOs Putty

Status

Not yet recruiting

Source

Kuros Biosurgery AG

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:23-0400

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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.

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

The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.

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