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Five-Plus Year Follow-Up of SMART Randomized Controlled Trial (SMART)

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ClinicalTrials.gov Identifier: NCT03997825
Recruitment Status : Completed
First Posted : June 25, 2019
Results First Posted : November 4, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Relievant Medsystems, Inc.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain


Intervention Details:
  • Device: Basivertebral Nerve (BVN) Ablation
    Single follow-up visit of previously treated participants from the SMART trial.


Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • LBP at least 6 months from original SMART Trial
  • RF Ablation Arm from SMART Trial

Exclusion Criteria:

-Control Arm Subjects from SMART Trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997825


Locations
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United States, Arizona
Desert Institute for Spine Care
Phoenix, Arizona, United States, 85020
United States, California
SpineCare Medical Group
Daly City, California, United States, 94015
Memorial Orthopedic Surgical Group
Long Beach, California, United States, 90806
Cedars Sinai Spine Center
Los Angeles, California, United States, 90048
United States, Georgia
Drug Studies of America
Marietta, Georgia, United States, 30060
United States, Indiana
Indiana Spine Group
Carmel, Indiana, United States, 46032
United States, Maine
Maine Medical Partners
Scarborough, Maine, United States, 04074
United States, Michigan
Michigan Orthopedics Instititute
Southfield, Michigan, United States, 48033
United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
United States, Oregon
Pacific Sports and Spine
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Rothman Orthopedic Institute
Bensalem, Pennsylvania, United States, 19020
United States, Texas
Seton Spine and Scoliosis Center
Austin, Texas, United States, 78731
United States, Virginia
Virginia iSpine Physicians
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Relievant Medsystems, Inc.
Investigators
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Principal Investigator: Jeff Fischgrund, MD William Beaumont Hospitals
  Study Documents (Full-Text)

Documents provided by Relievant Medsystems, Inc.:
Study Protocol  [PDF] April 5, 2019
Statistical Analysis Plan  [PDF] November 5, 2019

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Responsible Party: Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier: NCT03997825    
Other Study ID Numbers: CIP 0011
First Posted: June 25, 2019    Key Record Dates
Results First Posted: November 4, 2020
Last Update Posted: January 13, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations