Trial Outcomes & Findings for The MiDAS ENCORE Study (NCT NCT02093520)
NCT ID: NCT02093520
Last Updated: 2017-12-06
Results Overview
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
12 months
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
153
|
|
Overall Study
COMPLETED
|
143
|
131
|
|
Overall Study
NOT COMPLETED
|
6
|
22
|
Reasons for withdrawal
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Overall Study
Not treated
|
6
|
22
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MILD
n=149 Participants
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
n=153 Participants
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 Years
STANDARD_DEVIATION 7.0 • n=149 Participants
|
75.0 Years
STANDARD_DEVIATION 7.0 • n=153 Participants
|
75.3 Years
STANDARD_DEVIATION 7.0 • n=302 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=149 Participants
|
95 Participants
n=153 Participants
|
170 Participants
n=302 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=149 Participants
|
58 Participants
n=153 Participants
|
132 Participants
n=302 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
149 Participants
n=149 Participants
|
153 Participants
n=153 Participants
|
302 Participants
n=302 Participants
|
|
ODI
|
53.0 units on a scale
STANDARD_DEVIATION 12.9 • n=149 Participants
|
51.7 units on a scale
STANDARD_DEVIATION 12.0 • n=153 Participants
|
52.3 units on a scale
STANDARD_DEVIATION 12.4 • n=302 Participants
|
|
NPRS
|
7.7 units on a scale
STANDARD_DEVIATION 1.4 • n=149 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 1.3 • n=153 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 1.4 • n=302 Participants
|
|
ZCQ
Symptom Severity
|
3.5 units on a scale
STANDARD_DEVIATION 0.5 • n=149 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.6 • n=153 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.6 • n=302 Participants
|
|
ZCQ
Physical Function
|
2.9 units on a scale
STANDARD_DEVIATION 0.5 • n=149 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.4 • n=153 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.5 • n=302 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
Outcome measures
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
n=143 Participants
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
n=129 Participants
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
|
83 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.
Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Outcome measures
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
n=143 Participants
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
n=129 Participants
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
|
82 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.
Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Outcome measures
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
n=143 Participants
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
n=129 Participants
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Symptom Severity
|
74 Participants
|
41 Participants
|
|
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Physical Function
|
63 Participants
|
23 Participants
|
|
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Patient Satisfaction
|
88 Participants
|
43 Participants
|
Adverse Events
Minimally Invasive Lumbar Decompression (MILD)
Serious events: 18 serious events
Other events: 2 other events
Deaths: 2 deaths
Epidural Steroid Injection (ESI)
Serious events: 13 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
n=149 participants at risk
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
n=153 participants at risk
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorders
|
4.0%
6/149 • Number of events 6
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
3.3%
5/153 • Number of events 5
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.67%
1/149 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
General disorders
General disorders and administration site conditions
|
0.00%
0/149
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
1.3%
2/153 • Number of events 2
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Infections and infestations
Infections and infestations
|
3.4%
5/149 • Number of events 5
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.7%
4/149 • Number of events 4
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
2.6%
4/153 • Number of events 6
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.67%
1/149 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecifie
|
0.67%
1/149 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Nervous system disorders
Nervous system disorders
|
0.67%
1/149 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.00%
0/153
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.0%
3/149 • Number of events 4
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.00%
0/153
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.67%
1/149 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
Other adverse events
| Measure |
Minimally Invasive Lumbar Decompression (MILD)
n=149 participants at risk
Image guided minimally-invasive lumbar decompression
Minimally Invasive 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.
|
Epidural Steroid Injection (ESI)
n=153 participants at risk
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/149
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 1
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
1.3%
2/149 • Number of events 2
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.00%
0/153
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/149
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
0.65%
1/153 • Number of events 2
For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place