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Satellite™ PEEK Nucleus Replacement Retrospective Analysis

2014-08-27 03:14:11 | BioPortfolio

Summary

The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.

The purpose of this study is to evaluate adverse event (AE) rate and early clinical effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data collection will include information on health related quality of life (QoL), physical functioning and adverse event after nucleus replacement surgery. Radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion.

All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Conditions

Degenerative Disc Disease, Lumbar

Location

Masaryk Hospital
Usti nad Labem
Czech Republic

Status

Enrolling by invitation

Source

Medtronic Spinal and Biologics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:11-0400

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Medical and Biotech [MESH] Definitions

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

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

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.

Outgrowth of immature bony processes or bone spurs (OSTEOPHYTE) from the VERTEBRAE, reflecting the presence of degenerative disease and calcification. It commonly occurs in cervical and lumbar SPONDYLOSIS.

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.

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