Trial Outcomes & Findings for SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (NCT NCT01446419)

Last Updated: 2016-10-31

Results Overview

The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain. ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

225 participants

Primary outcome timeframe

3 months

Results posted on

2016-10-31

Participant Flow

Subjects were screened and enrolled at 15 sites in the US and 3 sites in Germany

2:1 Randomization (treatment: sham)

Participant milestones

Participant milestones
Measure	Intracept Treatment Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Overall Study STARTED	147	78
Overall Study 3 Month Follow-up	146	77
Overall Study 6 Month Follow-up	144	77
Overall Study 12 Month Follow-up	142	77
Overall Study COMPLETED	142	77
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intracept Treatment Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Terminated per protocol	3	0

Baseline Characteristics

SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intracept Treatment n=147 Participants Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment n=78 Participants Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.	Total n=225 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment United States	133 participants n=93 Participants	69 participants n=4 Participants	202 participants n=27 Participants
Region of Enrollment Germany	14 participants n=93 Participants	9 participants n=4 Participants	23 participants n=27 Participants
Oswestry Disability Index (ODI)	42.9 units on a scale STANDARD_DEVIATION 10.73 • n=93 Participants	41.1 units on a scale STANDARD_DEVIATION 10.39 • n=4 Participants	42.2 units on a scale STANDARD_DEVIATION 10.63 • n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	138 Participants n=93 Participants	74 Participants n=4 Participants	212 Participants n=27 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Age, Continuous	46.9 years STANDARD_DEVIATION 10.46 • n=93 Participants	47.1 years STANDARD_DEVIATION 8.97 • n=4 Participants	47.0 years STANDARD_DEVIATION 9.95 • n=27 Participants
Gender Female	65 Participants n=93 Participants	37 Participants n=4 Participants	102 Participants n=27 Participants
Gender Male	82 Participants n=93 Participants	41 Participants n=4 Participants	123 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=93 Participants	73 Participants n=4 Participants	211 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	134 Participants n=93 Participants	71 Participants n=4 Participants	205 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.

Outcome measures

Outcome measures
Measure	Intracept Treatment n=128 Participants Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment n=77 Participants Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Change in ODI From Baseline to 3 Months Post-treatment	-20.5 units on a scale Interval -23.2 to -17.8	-15.2 units on a scale Interval -18.7 to -11.7

SECONDARY outcome

Timeframe: 3 months

Proportion of subjects with clinical success at 3 months, where clinical success was defined as: * 3 month ODI score represented at least a 15-point reduction from baseline * no device or procedure related SAE between baseline and 3 mos. * no increase in opioid use between procedure and 3 mos. * no deficit in a motor or dermatomal sensory group at the treated level at 3 mos. * no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos.

Outcome measures

Outcome measures
Measure	Intracept Treatment n=128 Participants Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment n=77 Participants Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Patient Success at 3 Months	55.5 percentage of patients	45.5 percentage of patients

SECONDARY outcome

Timeframe: 6 months

The improvement in ODI at 6 months compared to baseline. ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.

Outcome measures

Outcome measures
Measure	Intracept Treatment n=128 Participants Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment n=77 Participants Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Change in ODI From Baseline to 6 Months Post-treatment	-20.8 units on a scale Interval -23.4 to -18.2	-17.0 units on a scale Interval -20.3 to -13.7

Adverse Events

Intracept Treatment

Serious events: 9 serious events

Other events: 78 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intracept Treatment n=147 participants at risk Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment n=78 participants at risk Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Infections and infestations Gastrointestinal bacterial infection	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Injury, poisoning and procedural complications Airway obstruction on anaesthetic induction	0.00% 0/147 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	1.3% 1/78 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Injury, poisoning and procedural complications Complications from lymph node excision	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Musculoskeletal and connective tissue disorders Arthritis aggravated	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Musculoskeletal and connective tissue disorders Neck pain	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Musculoskeletal and connective tissue disorders Low back pain	1.4% 2/147 • Number of events 2 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Nervous system disorders Grand mal seizure	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Nervous system disorders CVA	0.00% 0/147 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	1.3% 1/78 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Surgical and medical procedures C-section	0.00% 0/147 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	1.3% 1/78 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Surgical and medical procedures Hip replacement	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	1.3% 1/78 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Surgical and medical procedures Bladder operation	0.68% 1/147 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	0.00% 0/78 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Vascular disorders Deep vein thrombosis	0.00% 0/147 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	1.3% 1/78 • Number of events 1 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up

Other adverse events

Other adverse events
Measure	Intracept Treatment n=147 participants at risk Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.	Sham Treatment n=78 participants at risk Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Injury, poisoning and procedural complications Incision site discomfort	11.6% 17/147 • Number of events 17 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	6.4% 5/78 • Number of events 5 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Musculoskeletal and connective tissue disorders Leg pain	8.2% 12/147 • Number of events 12 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	5.1% 4/78 • Number of events 4 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Musculoskeletal and connective tissue disorders Low back pain	23.1% 34/147 • Number of events 35 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	14.1% 11/78 • Number of events 11 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
Injury, poisoning and procedural complications Post procedural nausea	10.2% 15/147 • Number of events 15 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up	5.1% 4/78 • Number of events 4 • 12 Months Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up

Additional Information

V.P. of Clinical & Regulatory Affairs

Relievant Medsystems, Inc.

Phone: 650-261-2259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Individual PIs will not publish any study results until completion of study and publication of the multi-center results in a peer-reviewed journal, which shall occur within one year after study completion. Thereafter, PIs may publish individual site experience. Sponsor can review results communications prior to public release and can embargo communications regarding results for a period that is less than or equal to 60 days from the time submitted to sponsor for review.
Publication restrictions are in place

Restriction type: OTHER