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The MiDAS ENCORE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02093520
Recruitment Status : Completed
First Posted : March 21, 2014
Results First Posted : July 17, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Interventions Procedure: MILD Procedure
Drug: Epidural Steroid Injection
Enrollment 302
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 149 153
Completed 143 131
Not Completed 6 22
Reason Not Completed
Not treated             6             22
Arm/Group Title MILD Epidural Steroid Injection (ESI) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 149 153 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 153 participants 302 participants
75.6  (7.0) 75.0  (7.0) 75.3  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 153 participants 302 participants
Female
75
  50.3%
95
  62.1%
170
  56.3%
Male
74
  49.7%
58
  37.9%
132
  43.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 149 participants 153 participants 302 participants
149
 100.0%
153
 100.0%
302
 100.0%
ODI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 149 participants 153 participants 302 participants
53.0  (12.9) 51.7  (12.0) 52.3  (12.4)
[1]
Measure Description:

The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire.

0 to 20: Minimal disability 21-40: Moderate Disability 41-60: Severe Disability 61-80: Crippling back pain 81-100: These patients are either bed-bound or have an exaggeration of their symptoms.

NPRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 149 participants 153 participants 302 participants
7.7  (1.4) 7.8  (1.3) 7.8  (1.4)
[1]
Measure Description: The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
ZCQ   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Symptom Severity Number Analyzed 149 participants 153 participants 302 participants
3.5  (0.5) 3.5  (0.6) 3.5  (0.6)
Physical Function Number Analyzed 149 participants 153 participants 302 participants
2.9  (0.5) 2.8  (0.4) 2.8  (0.5)
[1]
Measure Description:

The Zurich Claudication Questionnaire (ZCQ) is a disease-specific self-report outcome. The ZCQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. The scale relates to symptoms over the past month.

ZCQ consists of three subscales:

  1. Symptom severity scale (questions I-VII) Possible range of the score is 1 to 5.
  2. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4.
  3. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
1.Primary Outcome
Title Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 143 129
Measure Type: Count of Participants
Unit of Measure: Participants
83
  58.0%
35
  27.1%
2.Secondary Outcome
Title Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 143 129
Measure Type: Count of Participants
Unit of Measure: Participants
82
  57.3%
35
  27.1%
3.Secondary Outcome
Title Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 143 129
Measure Type: Count of Participants
Unit of Measure: Participants
Symptom Severity
74
  51.7%
41
  31.8%
Physical Function
63
  44.1%
23
  17.8%
Patient Satisfaction
88
  61.5%
43
  33.3%
Time Frame [Not Specified]
Adverse Event Reporting Description For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
 
Arm/Group Title Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Hide Arm/Group Description

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.

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

All-Cause Mortality
Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/149 (1.34%)      0/153 (0.00%)    
Hide Serious Adverse Events
Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/149 (12.08%)      13/153 (8.50%)    
Cardiac disorders     
Cardiac Disorders  6/149 (4.03%)  6 5/153 (3.27%)  5
Gastrointestinal disorders     
Gastrointestinal Disorders  1/149 (0.67%)  1 1/153 (0.65%)  1
General disorders     
General disorders and administration site conditions  0/149 (0.00%)  0 2/153 (1.31%)  2
Infections and infestations     
Infections and infestations  5/149 (3.36%)  5 1/153 (0.65%)  1
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  4/149 (2.68%)  4 4/153 (2.61%)  6
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1/149 (0.67%)  1 1/153 (0.65%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecifie  1/149 (0.67%)  1 1/153 (0.65%)  1
Nervous system disorders     
Nervous system disorders  1/149 (0.67%)  1 0/153 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  3/149 (2.01%)  4 0/153 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures  1/149 (0.67%)  1 1/153 (0.65%)  1
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Minimally Invasive Lumbar Decompression (MILD) Epidural Steroid Injection (ESI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/149 (1.34%)      2/153 (1.31%)    
Cardiac disorders     
Cardiac disorders 1 [1]  0/149 (0.00%)  0 1/153 (0.65%)  1
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications 1 [1]  2/149 (1.34%)  2 0/153 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders 1 [1]  0/149 (0.00%)  0 1/153 (0.65%)  2
1
Term from vocabulary, MedDRA (18.0)
[1]
Procedure related adverse event
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP of Clinical Affairs
Organization: Vertos Medical
Phone: 9493490008
EMail: kdavis@vertosmed.com
Layout table for additonal information
Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT02093520    
Other Study ID Numbers: MiDAS ENCORE
First Submitted: March 18, 2014
First Posted: March 21, 2014
Results First Submitted: May 23, 2017
Results First Posted: July 17, 2017
Last Update Posted: December 6, 2017