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

NCT03997825 | Completed Results FDA Device

• 1 other identifier: CIP 0011
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• LS Mean Reduction in VAS From Baseline

  Difference between baseline and 5 year post treatment measurements

• Responder Rates

  At 5 year post treatment

• Narcotics Use

  Difference between baseline and 5 years post treatment.

• Injections

  Difference from baseline percentage measurement to 5 years post treatment measurement

• Interventions

  Measured form treatment data to 5 years post treatment visit date

Interventions

Basivertebral Nerve (BVN) Ablation DEVICE

Single follow-up visit of previously treated participants from the SMART trial.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Control Arm Subjects from SMART Trial

Sponsors & Collaborators

• Relievant Medsystems, Inc.: lead

Study Sites (13)

Desert Institute for Spine Care

Phoenix, Arizona, 85020, United States

Location

SpineCare Medical Group

Daly City, California, 94015, United States

Location

Memorial Orthopedic Surgical Group

Long Beach, California, 90806, United States

Location

Cedars Sinai Spine Center

Los Angeles, California, 90048, United States

Location

Drug Studies of America

Marietta, Georgia, 30060, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Maine Medical Partners

Scarborough, Maine, 04074, United States

Location

Michigan Orthopedics Instititute

Southfield, Michigan, 48033, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Pacific Sports and Spine

Eugene, Oregon, 97401, United States

Location

Rothman Orthopedic Institute

Bensalem, Pennsylvania, 19020, United States

Location

Seton Spine and Scoliosis Center

Austin, Texas, 78731, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

Results Point of Contact

• Title: Diane Sahr, VP of Clinical Research
• Organization: Relievant Medsystems

dsahr@relievant.com

(650) 368-1000

Study Officials

• Jeff Fischgrund, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: June 25, 2019
• Study Start: June 13, 2019
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: January 13, 2021
• Results First Posted: November 4, 2020

Record last verified: 2020-12

Locations

US (13)