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| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
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Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.
This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Medtronic neurostimulator | Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). |
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Inclusion Criteria:
Exclusion Criteria:
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All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Christine DJIAN, MD | Hôpital Saint Anne, Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Foch - 40 rue Worth | Suresnes | 92151 | France |
Not applicable; this study was non-randomized in which no treatment group was assigned.
The first subject enrolled in the study on January 13, 2012. The last subject was enrolled on December 19, 2013 and the last visit of the last subject was on January 11, 2016. A total of 414 patients were assessed for eligibility, across 28 sites in France, of which, 402 subjects were included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primo-implant (PI) | Subjects implanted for the first time with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation. |
| FG001 | Replacement (RP) | Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices, in order to document the integrality of the practice and collect long-term data like complications and definitive explants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study - Full Analysis Set (FAS) |
| |||||||||||||
| Intention-To-Treat (ITT) - Completer |
|
FAS includes all subjects from primo-implant (n=264) and replacement (n=138) groups enrolled in the study with a valid Patient Data Release Form. 402 subjects were analyzed in the FAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Primo-implant (PI) | Subjects implanted for the first time (primary implant group) with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation. |
| BG001 | Replacement (RP) |
| 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 | Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. | Posted | Number | 95% Confidence Interval | Percentage of responders | 2 years |
|
Adverse events were collected from enrollment through the study end.
Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
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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 | Full Analysis Set (FAS) | FAS includes all subjects from primo-implant (n=264) and replacement (n=138) groups enrolled in the study with a valid Patient Data Release Form. 402 subjects were analyzed in the FAS. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA | Systematic Assessment |
The targeted pain area of the therapy was assumed to be the one with the predominant NPRS score at baseline. For the replacement group it was unknown if the therapy was active at the time of the device replacement (enrollment).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neuromodulation, Clinical Study Management | Medtronic | medtronicneurotrials@medtronic.com |
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| 1 year and 2 years |
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | 1 year |
| Concomitant Pain Relief Medication | Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years. | Baseline, 1 and 2 years |
| Dose of Analgesics Level 3 (Morphinics) | Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years. | Baseline, 1 and 2 years |
| Patient Satisfaction | Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating "pain relief improvement," "daily life improvement," "rather satisfied with the treatment," or "would agree to the treatment again"). | 1 and 2 years |
| Return to Work | Percentage of subjects being invalid at inclusion and active at 1 and 2 years. | 1 and 2 years |
| NOT COMPLETED |
|
Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices (replacement group), in order to document the integrality of the practice and collect long-term data like complications and definitive explants.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. | Posted | Number | 95% Confidence Interval | Percentage of responders | 1 year and 2 years |
|
|
|
| Secondary | Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. | Posted | Number | 95% Confidence Interval | Percentage of responders | 1 year |
|
|
|
| Secondary | Concomitant Pain Relief Medication | Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years. | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. | Posted | Number | 95% Confidence Interval | Percentage of subject taking drug | Baseline, 1 and 2 years |
|
|
|
| Secondary | Dose of Analgesics Level 3 (Morphinics) | Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years. | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. Here, patients taking analgesics level 3 medications were considered. | Posted | Mean | Standard Deviation | Daily equivalent morphine dose in mg | Baseline, 1 and 2 years |
|
|
|
| Secondary | Patient Satisfaction | Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating "pain relief improvement," "daily life improvement," "rather satisfied with the treatment," or "would agree to the treatment again"). | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. | Posted | Number | 95% Confidence Interval | Percentage of subjects satisfied | 1 and 2 years |
|
|
|
| Secondary | Return to Work | Percentage of subjects being invalid at inclusion and active at 1 and 2 years. | ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed. | Posted | Number | Percentage of subjects | 1 and 2 years |
|
|
|
| 89 |
| 402 |
| 105 |
| 402 |
| Peritonitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Allodynia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Intercostal neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Motor dysfunction | Nervous system disorders | MedDRA | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Phantom pain | Nervous system disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Death | General disorders | MedDRA | Systematic Assessment |
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| Device battery issue | General disorders | MedDRA | Systematic Assessment |
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| Device dislocation | General disorders | MedDRA | Systematic Assessment |
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| Device end of service | General disorders | MedDRA | Systematic Assessment |
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| Device extension damage | General disorders | MedDRA | Systematic Assessment |
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| Device issue | General disorders | MedDRA | Systematic Assessment |
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| Device lead damage | General disorders | MedDRA | Systematic Assessment |
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| Device lead issue | General disorders | MedDRA | Systematic Assessment |
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| Device stimulation issue | General disorders | MedDRA | Systematic Assessment |
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| Implant site hyperaesthesia | General disorders | MedDRA | Systematic Assessment |
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| Implant site inflammation | General disorders | MedDRA | Systematic Assessment |
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| Implant site pain | General disorders | MedDRA | Systematic Assessment |
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| Medical device discomfort | General disorders | MedDRA | Systematic Assessment |
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| Medical device site pain | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
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| Surgical skin tear | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Medical device removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
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| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA | Systematic Assessment |
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| Meningocele acquired | Nervous system disorders | MedDRA | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
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| Spinal claudication | Nervous system disorders | MedDRA | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
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| Implant site haematoma | Vascular disorders | MedDRA | Systematic Assessment |
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| Subcutaneous hematoma | Vascular disorders | MedDRA | Systematic Assessment |
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| Syncope | Vascular disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Device dislocation | General disorders | MedDRA | Systematic Assessment |
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| Device ineffective | General disorders | MedDRA | Systematic Assessment |
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| Device intolerance | General disorders | MedDRA | Systematic Assessment |
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| Device stimulation issue | General disorders | MedDRA | Systematic Assessment |
|
| Implant site discolouration | General disorders | MedDRA | Systematic Assessment |
|
| Implant site hematoma | General disorders | MedDRA | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA | Systematic Assessment |
|
| Lead dislodgement | General disorders | MedDRA | Systematic Assessment |
|
| Medical device discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Necrosis | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
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| Therapeutic product ineffective | General disorders | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Neurostimulator removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
It is stated in the CIP and Agreement signed by the investigators that the French SCS Registry data are the sole property of Medtronic.
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| Analgesic, level 3 |
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| NSAID |
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| Antiepileptic |
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| Antidepressant |
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| treatment satisfaction |
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| agree to the treatment again |
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