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

Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Desert Institute for Spine Care
  • California
    • Daly City, California, United States, 94015
      • SpineCare Medical Group
    • Long Beach, California, United States, 90806
      • Memorial Orthopedic Surgical Group
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Spine Center
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Drug Studies of America
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners
  • Michigan
    • Southfield, Michigan, United States, 48033
      • Michigan Orthopedics Instititute
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports and Spine
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Rothman Orthopedic Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Seton Spine and Scoliosis Center
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia iSpine Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Relievant Medsystems, Inc.
• Investigators: Principal Investigator: Jeff Fischgrund, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIP 0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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