Trial Outcomes & Findings for MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study (NCT NCT01315145)
NCT ID: NCT01315145
Last Updated: 2015-08-31
Results Overview
The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
16 weeks
Results posted on
2015-08-31
Participant Flow
Participant milestones
| Measure |
Percutaneous Lumbar Decompression
Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
|
Lumbar Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
16
|
|
Overall Study
COMPLETED
|
105
|
11
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Baseline characteristics by cohort
| Measure |
Percutaneous Lumbar Decompression
n=122 Participants
Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
|
Lumbar Epidural Steroid Injection
n=16 Participants
Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.9 Years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
69.94 Years
STANDARD_DEVIATION 9.73 • n=7 Participants
|
72.56 Years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All participants who reported 16 week outcomes are included in this analysis.
The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.
Outcome measures
| Measure |
Percutaneous Lumbar Decompression
n=114 Participants
Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
|
Lumbar Epidural Steroid Injection
n=13 Participants
Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
|
65.71 percentage of responders
|
46.15 percentage of responders
|
Adverse Events
Percutaneous Lumbar Decompression
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Lumbar Epidural Steroid Injection
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Percutaneous Lumbar Decompression
n=122 participants at risk
Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
|
Lumbar Epidural Steroid Injection
n=16 participants at risk
Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Infections and infestations
FEVER (HOSPITALIZED)
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
PROGRESSION OF SPINAL STENOSIS
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
CHEST PAIN
|
0.00%
0/122
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
ORTHOSTASIS
|
0.00%
0/122
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
SUBARACHNOID HEMORRHAGE
|
0.00%
0/122
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
SUBDURAL HEMATOMA
|
0.00%
0/122
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Percutaneous Lumbar Decompression
n=122 participants at risk
Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
|
Lumbar Epidural Steroid Injection
n=16 participants at risk
Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
RIGHT BUTTOCK PAIN DUE TO TRANSFORAMINAL STENOSIS
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
Heart Block
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
UTI
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
FALL
|
0.82%
1/122 • Number of events 2
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
EXACERBATION OF LEG PAIN
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
INTERMITTENT LEFT SIDE SACROILLIAC PAIN
|
0.82%
1/122 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
EXACERBATION OR RADICULAR PAIN RIGHT SIDE LEG
|
0.82%
1/122 • Number of events 2
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place