Satellite™ PEEK Nucleus Replacement Retrospective Analysis

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

Brief Summary

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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 number of adverse device effects (ADEs), serious adverse device effects (SADEs) and serious adverse event (SAEs) 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.

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Detailed Description

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Conditions

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Degenerative Disc Disease, Lumbar Disc Herniation, Lumbar

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient must have signed a Patient Data Release Form
* Age of at least 18 years and skeletally mature at the time of surgery

Exclusion Criterion:

* Patient has not reached the age of legal consent according to local laws

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No