N/A
Completed N=40
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
Degenerative Disc Disease, Lumbar · Disc Herniation, Lumbar
Source: ClinicalTrials.gov NCT01110967 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Aug 2014
Primary outcomePrimary: Health-related Quality of Life Using the Visual Analogue Scale for Back Pain — 5.5; 2.6; 2.2; 1.9 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-related Quality of Life Using the Visual Analogue Scale for Back Pain |
5.5; 2.6; 2.2; 1.9; 1.3 | — |
| PRIMARY Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain |
7.2; 1.8; 1.0; 0.3; 0.3 | — |
| PRIMARY Physical Functioning Using the Oswestry Disability Index (ODI) |
48.2; 23.2; 18.6; 17.5; 11.4 | — |
| PRIMARY Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs) |
7 | — |
| SECONDARY Range of Motion (ROM) at Implanted Level |
10.0; 14.3; 12.1; 14.9 | — |
| SECONDARY Intervertebral Disc Space (IVD) at Implanted Level |
0.30; 0.29; 0.28; 0.26; 0.26 | — |
| SECONDARY Device Subsidence Measured as Interbody Height Ratio (IBHR) |
1.9; 1.9; 1.7; 2.0 | — |
| SECONDARY Changes in Device Placement |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01110967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.