Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Conditions
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.
Interventions
None listed
Sponsors
Medtronic Spinal and Biologics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life Using the Visual Analogue Scale for Back Pain | Up to 12 months follow up visit | 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. |
| Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain | Up to 12 months follow up visit | 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. |
| Physical Functioning Using the Oswestry Disability Index (ODI) | Up to 12 months follow up visit | 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'. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion (ROM) at Implanted Level | Up to 12 months follow up visit | 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). |
| Intervertebral Disc Space (IVD) at Implanted Level | Up to 12 months follow up visit | 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. |
| Device Subsidence Measured as Interbody Height Ratio (IBHR) | Up to 12 months follow up visit | 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. |
| Changes in Device Placement | Up to 12 months follow up visit | — |
Countries
Czechia, Slovakia, Venezuela
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Implanted With a Satellite Device | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Patients Implanted With a Satellite Device |
|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Czech Republic | 2 participants |
| Region of Enrollment Slovakia | 8 participants |
| Region of Enrollment Venezuela | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 40 |
| serious Total, serious adverse events | 1 / 40 |
Outcome results
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.
Time frame: Up to 12 months follow up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Back Pain | Back pain pre-operative (n = 32) | 5.5 units on a scale | Standard Deviation 2.7 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Back Pain | Back pain at 1 month Follow up (n = 25) | 2.6 units on a scale | Standard Deviation 2.2 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Back Pain | Back pain at 3 months Follow up (n = 25) | 2.2 units on a scale | Standard Deviation 2.3 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Back Pain | Back pain at 6 months Follow up (n = 18) | 1.9 units on a scale | Standard Deviation 1.8 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Back Pain | Back pain at 12 months Follow up (n = 26) | 1.3 units on a scale | Standard Deviation 1.6 |
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.
Time frame: Up to 12 months follow up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain | Leg pain pre-operative (n = 30) | 7.2 units on a scale | Standard Deviation 2 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain | Leg pain at 1 month Follow up (n = 25) | 1.8 units on a scale | Standard Deviation 2.1 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain | Leg pain at 3 months Follow up (n = 25) | 1.0 units on a scale | Standard Deviation 1.3 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain | Leg pain at 6 months Follow up (n = 18) | 0.3 units on a scale | Standard Deviation 0.8 |
| Patients Implanted With a Satellite Device | Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain | Leg pain at 12 months Follow up (n = 26) | 0.3 units on a scale | Standard Deviation 0.8 |
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'.
Time frame: Up to 12 months follow up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Satellite Device | Physical Functioning Using the Oswestry Disability Index (ODI) | ODI pre-operative (n = 38) | 48.2 units on a scale | Standard Deviation 19.6 |
| Patients Implanted With a Satellite Device | Physical Functioning Using the Oswestry Disability Index (ODI) | ODI at 1 month Follow up (n = 26) | 23.2 units on a scale | Standard Deviation 16 |
| Patients Implanted With a Satellite Device | Physical Functioning Using the Oswestry Disability Index (ODI) | ODI at 3 months Follow up (n = 30) | 18.6 units on a scale | Standard Deviation 12.4 |
| Patients Implanted With a Satellite Device | Physical Functioning Using the Oswestry Disability Index (ODI) | ODI at 6 months Follow up (n = 23) | 17.5 units on a scale | Standard Deviation 13 |
| Patients Implanted With a Satellite Device | Physical Functioning Using the Oswestry Disability Index (ODI) | ODI at 12 months Follow up (n = 29) | 11.4 units on a scale | Standard Deviation 9.2 |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Implanted With a Satellite Device | Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs) | 7 events |
Secondary
Changes in Device Placement
Time frame: Up to 12 months follow up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Implanted With a Satellite Device | Changes in Device Placement | 1 participant |
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.
Time frame: Up to 12 months follow up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Satellite Device | Device Subsidence Measured as Interbody Height Ratio (IBHR) | IBHR at surgery (n = 34) | 1.9 ratio | Standard Deviation 0.2 |
| Patients Implanted With a Satellite Device | Device Subsidence Measured as Interbody Height Ratio (IBHR) | IBHR at 3 months Follow up (n = 20) | 1.9 ratio | Standard Deviation 0.2 |
| Patients Implanted With a Satellite Device | Device Subsidence Measured as Interbody Height Ratio (IBHR) | IBHR at 6 months Follow up (n = 18) | 1.7 ratio | Standard Deviation 0.2 |
| Patients Implanted With a Satellite Device | Device Subsidence Measured as Interbody Height Ratio (IBHR) | IBHR at 12 months Follow up (n = 21) | 2.0 ratio | Standard Deviation 0.7 |
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.
Time frame: Up to 12 months follow up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Satellite Device | Intervertebral Disc Space (IVD) at Implanted Level | IVD pre-operative (n = 35) | 0.30 mm | Standard Deviation 0.08 |
| Patients Implanted With a Satellite Device | Intervertebral Disc Space (IVD) at Implanted Level | IVD post-operative (n = 29) | 0.29 mm | Standard Deviation 0.07 |
| Patients Implanted With a Satellite Device | Intervertebral Disc Space (IVD) at Implanted Level | IVD at 3 months Follow up (n = 21) | 0.28 mm | Standard Deviation 0.07 |
| Patients Implanted With a Satellite Device | Intervertebral Disc Space (IVD) at Implanted Level | IVD at 6 months Follow up (n = 18) | 0.26 mm | Standard Deviation 0.06 |
| Patients Implanted With a Satellite Device | Intervertebral Disc Space (IVD) at Implanted Level | IVD at 12 months Follow up (n = 19) | 0.26 mm | Standard Deviation 0.06 |
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).
Time frame: Up to 12 months follow up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Satellite Device | Range of Motion (ROM) at Implanted Level | ROM pre-operative (n = 22) | 10.0 degrees | Standard Deviation 7.9 |
| Patients Implanted With a Satellite Device | Range of Motion (ROM) at Implanted Level | ROM at 3 month Follow up (n = 20) | 14.3 degrees | Standard Deviation 5.8 |
| Patients Implanted With a Satellite Device | Range of Motion (ROM) at Implanted Level | ROM at 6 month Follow up (n = 16) | 12.1 degrees | Standard Deviation 9.8 |
| Patients Implanted With a Satellite Device | Range of Motion (ROM) at Implanted Level | ROM at 12 month Follow up (n = 16) | 14.9 degrees | Standard Deviation 6.1 |