NCT01110967

Satellite™ PEEK Nucleus Replacement Retrospective Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Degenerative Disc Disease, Lumbar
• Disc Herniation, Lumbar

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-04-27
• Last updated: 2016-01-28
• Results posted: 2014-08-07

Locations

3 sites across 3 countries: Czechia, Slovakia, Venezuela