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The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basivertebral Nerve (BVN) Ablation | Device | Single follow-up visit of previously treated participants from the SMART trial. |
| Measure | Description | Time Frame |
|---|---|---|
| LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline | Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Difference in mean ODI at baseline and 5 years post treatment measurements. | Difference between baseline and 5 year post treatment measurements |
| Measure | Description | Time Frame |
|---|---|---|
| LS Mean Reduction in VAS From Baseline | Numeric pain scale with minimum of 0 to maximum of 10; with 0 being no pain and 10 being worst imaginable pain. Difference in mean VAS at baseline and at 5 years post treatment. | Difference between baseline and 5 year post treatment measurements |
| Responder Rates |
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Inclusion Criteria:
Exclusion Criteria:
-Control Arm Subjects from SMART Trial
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117 U.S. subjects treated per protocol in the treatment arm of the original SMART trial in the U.S.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Fischgrund, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Institute for Spine Care | Phoenix | Arizona | 85020 | United States | ||
| SpineCare Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | BVN Ablation Arm | Per protocol successfully treated United States participants randomized to BVN Ablation arm in the original SMART RCT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2019 | Oct 12, 2020 |
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Proportion of participants that achieve a threshold of > 15 point reduction in ODI and > 2 point reduction in VAS calculated as the difference between the baseline measurements and the 5 year post treatment measurements. |
| At 5 year post treatment |
| Narcotics Use | Proportion of participants using a narcotic more than once per week in the 30 days prior to the study visit. Difference in baseline to 5 year post treatment percentage measurements. | Difference between baseline and 5 years post treatment. |
| Injections | Proportion of participants receiving an injection for low back pain (adjudicated as same location and etiology as BVN ablation treatment) compared to baseline. Difference in percentage of participants at baseline and 5 years post treatment measurements. | Difference from baseline percentage measurement to 5 years post treatment measurement |
| Interventions | Proportion of participants receiving a pain intervention or surgery for low back pain (adjudicated as the same location and etiology as BVN ablation treatment) from procedure date to 5 year visit date. | Measured form treatment data to 5 years post treatment visit date |
| Daly City |
| California |
| 94015 |
| United States |
| Memorial Orthopedic Surgical Group | Long Beach | California | 90806 | United States |
| Cedars Sinai Spine Center | Los Angeles | California | 90048 | United States |
| Drug Studies of America | Marietta | Georgia | 30060 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Maine Medical Partners | Scarborough | Maine | 04074 | United States |
| Michigan Orthopedics Instititute | Southfield | Michigan | 48033 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Pacific Sports and Spine | Eugene | Oregon | 97401 | United States |
| Rothman Orthopedic Institute | Bensalem | Pennsylvania | 19020 | United States |
| Seton Spine and Scoliosis Center | Austin | Texas | 78731 | United States |
| Virginia iSpine Physicians | Richmond | Virginia | 23235 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BVN Ablation Arm | Randomized and successfully treated with basivertebral nerve ablation |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain-related disability (impact of low back pain on function) with a scale of 0 to 100. It is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be 10-12 points for minimally invasive procedures. | Mean | Standard Deviation | units on a scale |
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| Baseline Visual Analog Scale (VAS) | The VAS pain questionnaire involves a 10 cm scale scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate on the scale the degree of pain as an average level of low back pain for the last 7 days. Literature reports a minimally clinically important difference in VAS of 1.5 to 2.0 cm/point difference. | Mean | Standard Deviation | units on a scale |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline | Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Difference in mean ODI at baseline and 5 years post treatment measurements. | US per protocol BVN ablation treated participants who consented to participate | Posted | Least Squares Mean | Standard Deviation | units on a scale of 0 to 100 points | Difference between baseline and 5 year post treatment measurements |
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| Secondary | LS Mean Reduction in VAS From Baseline | Numeric pain scale with minimum of 0 to maximum of 10; with 0 being no pain and 10 being worst imaginable pain. Difference in mean VAS at baseline and at 5 years post treatment. | US per protocol BVN ablation treated participants who consented to participate | Posted | Least Squares Mean | Standard Deviation | score on a scale of 0 to 10 | Difference between baseline and 5 year post treatment measurements |
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| Secondary | Responder Rates | Proportion of participants that achieve a threshold of > 15 point reduction in ODI and > 2 point reduction in VAS calculated as the difference between the baseline measurements and the 5 year post treatment measurements. | US per protocol BVN ablation treated participants who consented to participate | Posted | Count of Participants | Participants | At 5 year post treatment |
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| Secondary | Narcotics Use | Proportion of participants using a narcotic more than once per week in the 30 days prior to the study visit. Difference in baseline to 5 year post treatment percentage measurements. | US per protocol BVN ablation treated participants that consented to participate | Posted | Count of Participants | Participants | Difference between baseline and 5 years post treatment. |
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| Secondary | Injections | Proportion of participants receiving an injection for low back pain (adjudicated as same location and etiology as BVN ablation treatment) compared to baseline. Difference in percentage of participants at baseline and 5 years post treatment measurements. | US per protocol BVN ablation treated participants that consented to participate | Posted | Count of Participants | Participants | Difference from baseline percentage measurement to 5 years post treatment measurement |
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| Secondary | Interventions | Proportion of participants receiving a pain intervention or surgery for low back pain (adjudicated as the same location and etiology as BVN ablation treatment) from procedure date to 5 year visit date. | US per protocol BVN ablation treated participants that consented to participate | Posted | Count of Participants | Participants | Measured form treatment data to 5 years post treatment visit date |
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5 years (mean of 6.4 years post BVN ablation)
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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 | BVN Ablation Arm | Randomized and successfully treated with basivertebral nerve ablation | 3 | 100 | 0 | 100 | 0 | 100 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Sahr, VP of Clinical Research | Relievant Medsystems | (650) 368-1000 | dsahr@relievant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2019 | Oct 12, 2020 | SAP_001.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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