Clinical trial NCT03997825: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Lead sponsor: Relievant Medsystems, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-25
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
timeFrame: Difference between baseline and 5 year post treatment measurements
Secondary outcomes:
measure: LS Mean Reduction in VAS From Baseline
timeFrame: Difference between baseline and 5 year post treatment measurements
measure: Responder Rates
timeFrame: At 5 year post treatment
measure: Narcotics Use
timeFrame: Difference between baseline and 5 years post treatment.
measure: Injections
timeFrame: Difference from baseline percentage measurement to 5 years post treatment measurement
measure: Interventions
timeFrame: Measured form treatment data to 5 years post treatment visit date
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Desert Institute for Spine Care
state: Arizona
city: Daly City
country: United States
facility: SpineCare Medical Group
state: California
city: Long Beach
country: United States
facility: Memorial Orthopedic Surgical Group
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Spine Center
state: California
city: Marietta
country: United States
facility: Drug Studies of America
state: Georgia
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Scarborough
country: United States
facility: Maine Medical Partners
state: Maine
city: Southfield
country: United States
facility: Michigan Orthopedics Instititute
state: Michigan
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Eugene
country: United States
facility: Pacific Sports and Spine
state: Oregon
city: Bensalem
country: United States
facility: Rothman Orthopedic Institute
state: Pennsylvania
city: Austin
country: United States
facility: Seton Spine and Scoliosis Center
state: Texas
city: Richmond
country: United States
facility: Virginia iSpine Physicians
state: Virginia
Study officials:
affiliation: William Beaumont Hospitals
name: Jeff Fischgrund, MD
role: PRINCIPAL_INVESTIGATOR
References: