Degenerative Disc Disease, Lumbar Clinical Trial
Official title:
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Masaryk Hospital | Usti nad Labem | |
| Slovakia | ÚVN SNP | Ružomberok | |
| Venezuela | Instituto de Columna de Caracas | Caracas |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Spinal and Biologics |
Czech Republic, Slovakia, Venezuela,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 12 months follow up visit | No |
| Primary | 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. | Up to 12 months follow up visit | No |
| Primary | 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'. | Up to 12 months follow up visit | No |
| Primary | Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs) | Patients were followed up according to the local practice, up to 1 year | Yes | |
| Secondary | 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). | Up to 12 months follow up visit | No |
| Secondary | 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. | Up to 12 months follow up visit | No |
| Secondary | 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. | Up to 12 months follow up visit | No |
| Secondary | Changes in Device Placement | Up to 12 months follow up visit | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00948831 -
Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
|
N/A |