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Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MILD | Active Comparator | The MILD procedure is an image-guided minimally-invasive lumbar decompression |
|
| Epidural Steroid Injection (ESI) | Active Comparator | An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MILD Procedure | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months | 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. | 12 months |
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Inclusion Criteria:
65 years or older and a Medicare beneficiary.
Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
LSS with neurogenic claudication diagnosed via:
Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
Available to complete 6 month and one year follow-up visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramsin Benyamin, MD | AAPM; ASIPP; ISIS; ASA | Principal Investigator |
| Peter Staats, MD | AAPM; ASIPP; ASA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synovation Medical Group | Chula Vista | California | 91914 | United States | ||
| Spine Intervention Medical Group/Fresno Surgical Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30199512 | Derived | Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868. | |
| 27228511 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months | 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. | 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. | Posted | Count of Participants | Participants | 12 months |
|
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For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders | MedDRA (18.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA (18.0) | Procedure related adverse event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Affairs | Vertos Medical | 9493490008 | kdavis@vertosmed.com |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Epidural Steroid Injection | Drug | 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 |
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. |
| 12 months |
| Fresno |
| California |
| 93710 |
| United States |
| The Spine Institute | Murrieta | California | 92563 | United States |
| Newport Beach Headache and Pain | Newport Beach | California | 92660 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61701 | United States |
| Frankfort Pain Clinic | Frankfort | Kentucky | 40601 | United States |
| MI Interventional Pain Center | Cherry Island | Michigan | 48183 | United States |
| Michigan Pain Specialist | Ypsilanti | Michigan | 48198 | United States |
| Mayo Clinic Pain Management | Rochester | Minnesota | 55905 | United States |
| Premier Pain | Shrewsbury | New Jersey | 07702 | United States |
| Southern Spine Institute | Mt. Pleasant | South Carolina | 29464 | United States |
| SC Spine and Pain Specialists | Myrtle Beach | South Carolina | 29572 | United States |
| Derived |
| Benyamin RM, Staats PS, MiDAS Encore I. MILD(R) Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016 May;19(4):229-42. |
| 26815247 | Derived | Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38. |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ODI | 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. | Mean | Standard Deviation | units on a scale |
|
| NPRS | 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"). | Mean | Standard Deviation | units on a scale |
|
| ZCQ | 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:
| Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
|
|
| Secondary | Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months | 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. | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | 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. | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 2 |
| 149 |
| 18 |
| 149 |
| 2 |
| 149 |
| EG001 | 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 | 0 | 153 | 13 | 153 | 2 | 153 |
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (18.0) |
|
| General disorders and administration site conditions | General disorders | MedDRA (18.0) |
|
| Infections and infestations | Infections and infestations | MedDRA (18.0) |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (18.0) |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (18.0) |
|
| Neoplasms benign, malignant and unspecifie | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) |
|
| Nervous system disorders | Nervous system disorders | MedDRA (18.0) |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (18.0) |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (18.0) | Procedure related adverse event |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Procedure related adverse event |
|
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| Patient Satisfaction |
|