Trial Outcomes & Findings for The STEPS - Totalis™ Trial (NCT NCT02079038)
NCT ID: NCT02079038
Last Updated: 2020-08-07
Results Overview
Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or selective nerve root block at index level(s) And no unblindings
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Baseline and 6 Months
Results posted on
2020-08-07
Participant Flow
180 subjects enrolled; 12 withdrew, leaving 168 subjects randomized \& treated.
Participant milestones
| Measure |
Totalis
Totalis™ Direct Decompression Procedure
|
Control Procedure
Comparator Surgical Procedure
|
|---|---|---|
|
Modified Intent to Treat Population
STARTED
|
112
|
56
|
|
Modified Intent to Treat Population
COMPLETED
|
105
|
51
|
|
Modified Intent to Treat Population
NOT COMPLETED
|
7
|
5
|
|
Completed 6 Months
STARTED
|
105
|
51
|
|
Completed 6 Months
COMPLETED
|
103
|
50
|
|
Completed 6 Months
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Totalis
Totalis™ Direct Decompression Procedure
|
Control Procedure
Comparator Surgical Procedure
|
|---|---|---|
|
Modified Intent to Treat Population
Withdrawal by Subject
|
6
|
5
|
|
Modified Intent to Treat Population
Death
|
1
|
0
|
|
Completed 6 Months
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
The STEPS - Totalis™ Trial
Baseline characteristics by cohort
| Measure |
Totalis
n=112 Participants
Totalis ™ Direct Decompression Procedure
|
Control Procedure
n=56 Participants
Comparator Surgical Procedure
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
70.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 MonthsWhere clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or selective nerve root block at index level(s) And no unblindings
Outcome measures
| Measure |
Totalis
n=103 Participants
Totalis ™ Direct Decompression Procedure
|
Control Procedure
n=50 Participants
Comparator Surgical Procedure
|
|---|---|---|
|
Percentage of Subjects With Clinically Significant Improvement in Outcomes
|
56.3 percentage of subjects
|
56.0 percentage of subjects
|
Adverse Events
Totalis
Serious events: 19 serious events
Other events: 98 other events
Deaths: 1 deaths
Control Procedure
Serious events: 11 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Totalis
n=112 participants at risk
Totalis™ Direct Decompression Procedure
|
Control Procedure
n=56 participants at risk
Comparator Surgical Procedure
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Cervical Instability
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Cardiac disorders
Coronary Artery Disease
|
0.89%
1/112 • Number of events 2 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain - Back and Leg
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Renal and urinary disorders
Renal Carcinoma
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Total Knee Replacement
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Injury, poisoning and procedural complications
Trauma from Fall
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.7%
3/112 • Number of events 3 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Blood and lymphatic system disorders
Anemia
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Vascular disorders
Aortic regurgitation
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Hepatobiliary disorders
Non-alcoholic cirrhosis
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Cardiac disorders
Death from atherosclerosis
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
General disorders
Dehydration
|
1.8%
2/112 • Number of events 2 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Hepatobiliary disorders
Gall stones
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Cardiac disorders
Heart failure
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
3.6%
2/56 • Number of events 2 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain -- Leg
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Knee osteoarthritis
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 2 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Infections and infestations
Respiratory infection
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Infections and infestations
Sepsis
|
0.00%
0/112 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
1.8%
1/56 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Subluxed patella
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain -- Toe
|
0.89%
1/112 • Number of events 1 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
Other adverse events
| Measure |
Totalis
n=112 participants at risk
Totalis™ Direct Decompression Procedure
|
Control Procedure
n=56 participants at risk
Comparator Surgical Procedure
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury, accidental
|
19.6%
22/112 • Number of events 34 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
17.9%
10/56 • Number of events 16 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain -- back
|
8.0%
9/112 • Number of events 9 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
12.5%
7/56 • Number of events 7 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain -- leg
|
13.4%
15/112 • Number of events 16 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
16.1%
9/56 • Number of events 13 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain -- buttocks or groin
|
8.9%
10/112 • Number of events 11 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
3.6%
2/56 • Number of events 3 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Nervous system disorders
Neurologiocal disorder, any
|
8.9%
10/112 • Number of events 17 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
7.1%
4/56 • Number of events 7 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis symptoms at index level
|
12.5%
14/112 • Number of events 19 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
10.7%
6/56 • Number of events 8 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Renal and urinary disorders
Urinary tract infection
|
7.1%
8/112 • Number of events 12 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
0.00%
0/56 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
8.9%
10/112 • Number of events 11 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
7.1%
4/56 • Number of events 5 • 6 Months
Serious Adverse Events assessed at study visits from Surgical Procedure Visit to End of Study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60