Satellite™ PEEK Nucleus Replacement Retrospective Analysis
Status
Conditions
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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