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.
Study Type
OBSERVATIONAL
Enrollment
40
Masaryk Hospital
Ústí nad Labem, Czechia
ÚVN SNP
Ružomberok, Slovakia
Instituto de Columna de Caracas
Caracas, Venezuela
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain
The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.
Time frame: Up to 12 months follow up visit
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain
The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.
Time frame: Up to 12 months follow up visit
Physical Functioning Using the Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.
Time frame: Up to 12 months follow up visit
Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)
Time frame: Patients were followed up according to the local practice, up to 1 year
Range of Motion (ROM) at Implanted Level
The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).
Time frame: Up to 12 months follow up visit
Intervertebral Disc Space (IVD) at Implanted Level
The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as \[(A+B)/2\]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.
Time frame: Up to 12 months follow up visit
Device Subsidence Measured as Interbody Height Ratio (IBHR)
Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.
Time frame: Up to 12 months follow up visit
Changes in Device Placement
Time frame: Up to 12 months follow up visit
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