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出境医 / 临床实验 / Five-Plus Year Follow-Up of SMART Randomized Controlled Trial (SMART)
Five-Plus Year Follow-Up of SMART Randomized Controlled Trial (SMART)
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Low Back Pain | Device: Basivertebral Nerve (BVN) Ablation |
Detailed Description:
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.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 117 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial |
| Actual Study Start Date : | June 13, 2019 |
| Actual Primary Completion Date : | November 8, 2019 |
| Actual Study Completion Date : | November 8, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline [ Time Frame: Difference between baseline and 5 year post treatment measurements ]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.
Secondary Outcome Measures :
- LS Mean Reduction in VAS From Baseline [ Time Frame: Difference between baseline and 5 year post treatment measurements ]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.
- Responder Rates [ Time Frame: At 5 year post treatment ]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.
- Narcotics Use [ Time Frame: Difference between baseline and 5 years post treatment. ]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.
- Injections [ Time Frame: Difference from baseline percentage measurement to 5 years post treatment measurement ]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.
- Interventions [ Time Frame: Measured form treatment data to 5 years post treatment visit date ]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.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 7, 2019 | ||||||
| First Posted Date | June 25, 2019 | ||||||
| Results First Submitted Date | October 12, 2020 | ||||||
| Results First Posted Date | November 4, 2020 | ||||||
| Last Update Posted Date | January 13, 2021 | ||||||
| Actual Study Start Date | June 13, 2019 | ||||||
| Actual Primary Completion Date | November 8, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline [ Time Frame: Difference between baseline and 5 year post treatment measurements ] 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.
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| Original Primary Outcome Measures |
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| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Five-Plus Year Follow-Up of SMART Randomized Controlled Trial | ||||||
| Official Title | Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description | 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. | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | 117 U.S. subjects treated per protocol in the treatment arm of the original SMART trial in the U.S. | ||||||
| Condition | Chronic Low Back Pain | ||||||
| Intervention | Device: Basivertebral Nerve (BVN) Ablation
Single follow-up visit of previously treated participants from the SMART trial.
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
117 | ||||||
| Original Estimated Enrollment |
133 | ||||||
| Actual Study Completion Date | November 8, 2019 | ||||||
| Actual Primary Completion Date | November 8, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: -Control Arm Subjects from SMART Trial |
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03997825 | ||||||
| Other Study ID Numbers | CIP 0011 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Relievant Medsystems, Inc. | ||||||
| Study Sponsor | Relievant Medsystems, Inc. | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Relievant Medsystems, Inc. | ||||||
| Verification Date | December 2020 | ||||||
