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To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReActiv8 Implantable Stimulation System | Device | Implantable electrical stimulation system. |
| Measure | Description | Time Frame |
|---|---|---|
| Low Back Pain - Numeric Pain Rating (NRS) Scale | Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain. | 90 days, 180 days, 1 year, 2 years post Activation |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Effects | All serious device- or procedure-related adverse events. | Through 2 years post Activation |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.
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The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Schu, MD | SANA Klinikum Duisburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopadisches Krankenhaus Schloss Werneck | Werneck | Balthasar-Neumann | 97440 | Germany | ||
| BG Klinikum Bergmannstrost |
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| ID | Title | Description |
|---|---|---|
| FG000 | ReActiv8 | All participants implanted with ReActiv8 at baseline. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ReActiv8 | All participants implanted with ReActiv8 at baseline. |
| 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 | Low Back Pain - Numeric Pain Rating (NRS) Scale | Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain. | Of the 87 patients implanted, 84 completed the Day 3 month, 85 completed the Day 6 month, 79 completed the Year 1 visit, and 74 completed the Year 2 visit. Some patients were withdrawn or lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 90 days, 180 days, 1 year, 2 years post Activation |
|
2 years
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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 | ReActiv8 | All participants implanted with ReActiv8 at baseline. | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain Sacroiliac | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
This study was an open-label registry with no formal statistical hypotheses. The sample size was based on the desire to gain a sufficient amount of representative data with the device in the post-market setting. It provides real-world data on the safety and performance of the device but is not a robust clinical trial, and thus, has the potential for bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Mainstay Medical | 877 702-8488 | clinical@mainstaymedical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2020 | May 30, 2024 | Prot_000.pdf |
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| Halle |
| Germany |
| Medizinisches Versorgungszentrum Steinburg gGmbH | Itzehoe | Germany |
| Katholisches Klinikum Koblenz | Koblenz | Germany |
| Klinikum Magdeburg | Magdeburg | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Numeric Pain Rating (NRS) Scale | The Numerical Rating Scale (NRS) is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain. | Mean | Standard Deviation | units on a scale |
|
| Oswestry Disability Index (ODI) | ODI is a disease specific questionnaire of the disabling effects of back pain and has 10 sections: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and travelling. Each section has 6 statements correlating to scores of 0 through 5, with the Subject choosing the statement that matches their ability. Scores from 0 to 20% indicate minimal disability; 21-40%, moderate disability; 41-60%, severe disability; 61-80%, crippled; and 81-100%, bedbound or exaggerating. A lower score means an improvement, or reduction in disability. | Mean | Standard Deviation | units on a scale |
|
| European Quality of Life - Five Dimensions (EQ-5D) | The European Quality of Life - Five Dimensions (EQ-5D) is a questionnaire of health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems, slight problems, moderate problems, severe problems, extreme problems) within a particular dimension. The EQ-5D Index is scored on a scale from -0.59 to 1.00, with a score of 1.00 indicating full health. A higher score means an improvement in health-related quality of life. | Mean | Standard Deviation | units on a scale |
|
| Opioid Use | Count of Participants | Participants |
|
| Pain Duration | Mean | Standard Deviation | years |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m 2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Serious Adverse Device Effects | All serious device- or procedure-related adverse events. | Posted | Count of Participants | Participants | Through 2 years post Activation |
|
|
|
| 87 |
| 21 |
| 87 |
| 6 |
| 87 |
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Herniated disc | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | Non-systematic Assessment |
|
| Vocal cord paresis | Nervous system disorders | Non-systematic Assessment |
|
| Prostatic Hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Arterial Bleeding | Vascular disorders | Non-systematic Assessment |
|
| Intervertebral Disc Prolapse | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Death; Cause Unknown, Unrelated to Study Treatment | General disorders | Non-systematic Assessment |
|
| Shoulder Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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