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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Intervertebral Disc Space (IVD) at Implanted Level |
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Inclusion Criteria:
Exclusion Criterion:
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All patients who were implanted with a Satellite™ Nucleus Replacement device at the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masaryk Hospital | Ústí nad Labem | Czechia | ||||
| ÚVN SNP |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Implanted With a Satellite Device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Implanted With a Satellite Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 12 months follow up visit |
|
|
Patients were followed up according to the local practice, up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Implanted With a Satellite Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Residual Radiculopathy | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Residual Radiculopathy | Musculoskeletal and connective tissue disorders |
Due to the retrospective design, it was not possible to report on SF-36 results and Modic endplate changes results as limited data was available in the patient records.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Faria | Medtronic Spinal & Biologics | +41 (0)21 802 70 00 | cristina.faria@medtronic.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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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 |
| 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 |
| Changes in Device Placement | Up to 12 months follow up visit |
| Ružomberok |
| Slovakia |
| Instituto de Columna de Caracas | Caracas | Venezuela |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 12 months follow up visit |
|
|
|
| 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'. | Posted | Mean | Standard Deviation | units on a scale | Up to 12 months follow up visit |
|
|
|
| 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). | Posted | Mean | Standard Deviation | degrees | Up to 12 months follow up visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mm | Up to 12 months follow up visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | Up to 12 months follow up visit |
|
|
|
| Secondary | Changes in Device Placement | Posted | Number | participant | Up to 12 months follow up visit |
|
|
|
| Primary | Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs) | Posted | Number | events | Patients were followed up according to the local practice, up to 1 year |
|
|
|
| 1 |
| 40 |
| 6 |
| 40 |
| Back pain and Sciatica | Musculoskeletal and connective tissue disorders |
|
| Low back pain | Musculoskeletal and connective tissue disorders |
|
Confidential Information shall not be disclosed and shall be sole property of sponsor during the term of the agreement and for 3 years after agreement termination. Results might be published or presented, however sponsor should receive publication for review at least 7 days prior to submittal. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed, to allow sponsor to protect its rights in copyrightable material, and to check for technical correctness.
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Leg pain at 6 months Follow up (n = 18) |
|
| Leg pain at 12 months Follow up (n = 26) |
|
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| ODI at 6 months Follow up (n = 23) |
|
| ODI at 12 months Follow up (n = 29) |
|
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| ROM at 12 month Follow up (n = 16) |
|
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| IVD at 6 months Follow up (n = 18) |
|
| IVD at 12 months Follow up (n = 19) |
|
|
| IBHR at 12 months Follow up (n = 21) |
|