Clinical trial NCT01110967: Satellite™ PEEK Nucleus Replacement Retrospective Analysis
Official title: Satellite™ PEEK Nucleus Replacement Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease, Lumbar
Disc Herniation, Lumbar
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were implanted with a Satellite™ Nucleus Replacement device at the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Health-related Quality of Life Using the Visual Analogue Scale for Back Pain
timeFrame: Up to 12 months follow up visit
measure: Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain
timeFrame: Up to 12 months follow up visit
measure: Physical Functioning Using the Oswestry Disability Index (ODI)
timeFrame: Up to 12 months follow up visit
measure: Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)
timeFrame: Patients were followed up according to the local practice, up to 1 year
Secondary outcomes:
measure: Range of Motion (ROM) at Implanted Level
timeFrame: Up to 12 months follow up visit
measure: Intervertebral Disc Space (IVD) at Implanted Level
timeFrame: Up to 12 months follow up visit
measure: Device Subsidence Measured as Interbody Height Ratio (IBHR)
timeFrame: Up to 12 months follow up visit
measure: Changes in Device Placement
timeFrame: Up to 12 months follow up visit
Other outcomes:
Locations:
city: Usti nad Labem
country: Czech Republic
facility: Masaryk Hospital
city: Ružomberok
country: Slovakia
facility: ÚVN SNP
city: Caracas
country: Venezuela
facility: Instituto de Columna de Caracas
Study officials:
References: