Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

• Sponsor: Coastal Orthopedics & Sports Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00995371
• Collaborator: Vertos Medical, Inc. (Industry)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spinal Stenosis	Device: MILD® (Minimally Invasive Lumbar Decompression); Drug: Epidural Steroid Injection	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study of Epidural Steroid Injection Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vertos mild® Minimally-Invasive Lumbar Decompression Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Device: MILD® (Minimally Invasive Lumbar Decompression); Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
Active Comparator: Epidural Steroid Injection Patients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use.	Drug: Epidural Steroid Injection; An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Outcome Measures

Primary Outcome Measures

1. Mean Change in VAS [Baseline and 6 weeks prior to cross-over]

   Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.

2. Mean Change in ODI [Baseline and 6 weeks prior to cross-over]

   Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value

3. Mean Change in VAS [Baseline and 26 weeks After ESI to mild cross-over]

   Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.

4. Mean Change in ODI [Baseline and 26 weeks After ESI to mild cross-over]

   Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.

• Prior failure of conservative therapy and ODI Score >20%.

• Radiologic evidence of LSS (L3-L5), Ligamentum flavum >2.5mm, confirmed by pre-op MRI and/or CT.

• Central canal cross sectional area ≤ 100 square mm.

• Anterior listhesis ≤ 5.0mm.

• Able to walk at least 10 feet unaided before being limited by pain.

• Available to complete 26 weeks of follow-up.

• A signed Informed Consent Form is obtained from the patient.

• Adults at least 18 years of age.

Exclusion Criteria:

• Prior surgery at intended treatment level.

• History of recent spinal fractures with concurrent pain symptoms.

• Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.)

• Significant / symptomatic disc protrusion or osteophyte formation.

• Excessive / symptomatic facet hypertrophy.

• Bleeding disorders and/or current use of anti-coagulants.

• Use of ASA and/or NSAID within 5 days of treatment.

• Pregnant and/or breastfeeding.

• Epidural steroids previously administered (not ESI naive)

• Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.

• Dementia and/or inability to give informed consent.

• Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.).

• On Workman's Compensation or considering litigation associated with back pain.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Orthopedics & Sports Medicine	Bradenton	Florida	United States	34209

Sponsors and Collaborators

• Coastal Orthopedics & Sports Medicine
• Vertos Medical, Inc.

Investigators

• Principal Investigator: Lora Brown, MD, Coastal Orthopedics & Sports Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coastal Orthopedics & Sports Medicine
• ClinicalTrials.gov Identifier: NCT00995371
• Other Study ID Numbers: VMD001LB
• First Posted: Oct 15, 2009
• Last Update Posted: Nov 15, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Coastal Orthopedics & Sports Medicine: Spinal Stenosis; Lumbar Spinal Stenosis; Laminotomy; Laminectomy; Spine Surgery
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	Patients were enrolled through one site (Coastal Orthopedics) between September 2009 and January 2011.
Pre-assignment Detail	Randomization occurred in blocks of four. After Week 6 post-treatment and prior to 4 months, ESI arm participants were allowed to cross over to mild if they chose to have it.

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	Epidural Steroid Injection Then Lumbar Decompression With Mild
Arm/Group Description	Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
Period Title: Prior to ESI Cross-over, 6 Weeks
STARTED	21	17
COMPLETED	21	17
NOT COMPLETED	0	0
Period Title: Prior to ESI Cross-over, 6 Weeks
STARTED	21	17
COMPLETED	16	12
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	Epidural Steroid Injection	Total
Arm/Group Description	Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.	Total of all reporting groups
Overall Participants	21	17	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 23.8%	1 5.9%	6 15.8%
>=65 years	16 76.2%	16 94.1%	32 84.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.24 (10.12)	78.71 (7.11)	76.26 (9.18)
Sex: Female, Male (Count of Participants)
Female	8 38.1%	9 52.9%	17 44.7%
Male	13 61.9%	8 47.1%	21 55.3%
Region of Enrollment (participants) [Number]
United States	21 100%	17 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in VAS
Description	Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.
Time Frame	Baseline and 6 weeks prior to cross-over

Outcome Measure Data

Analysis Population Description

All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	Epidural Steroid Injection Prior to Cross-Over
Arm/Group Description	Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
Measure Participants	21	17
Mean (95% Confidence Interval) [units on a scale]	2.52	0.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)
	Comments	The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.52
	Confidence Interval	(2-Sided) 95%; 1.09 to 3.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Epidural Steroid Injection Prior to Cross-Over
	Comments	The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -1.43 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Mean Change in ODI
Description	Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value
Time Frame	Baseline and 6 weeks prior to cross-over

Outcome Measure Data

Analysis Population Description

All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	Epidural Steroid Injection Prior to Cross-Over
Arm/Group Description	Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
Measure Participants	21	17
Mean (95% Confidence Interval) [units on a scale]	11.33	5.65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)
	Comments	The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.33
	Confidence Interval	(2-Sided) 95%; 3.35 to 19.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Epidural Steroid Injection Prior to Cross-Over
	Comments	The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.65
	Confidence Interval	() 95%; -4.12 to 15.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Mean Change in VAS
Description	Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.
Time Frame	Baseline and 26 weeks After ESI to mild cross-over

Outcome Measure Data

Analysis Population Description

Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	Epidural Steroid Injection Then Lumbar Decompression With Mild
Arm/Group Description	Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
Measure Participants	16	12
Mean (95% Confidence Interval) [units on a scale]	2.19	1.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)
	Comments	The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.19
	Confidence Interval	() 95%; 0.61 to 3.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Epidural Steroid Injection Prior to Cross-Over
	Comments	The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.00
	Confidence Interval	() 95%; -0.66 to 2.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Mean Change in ODI
Description	Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value
Time Frame	Baseline and 26 weeks After ESI to mild cross-over

Outcome Measure Data

Analysis Population Description

Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	Epidural Steroid Injection Then Lumbar Decompression With Mild
Arm/Group Description	Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
Measure Participants	16	12
Mean (95% Confidence Interval) [units on a scale]	16.13	6.17

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)
	Comments	The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.13
	Confidence Interval	() 95%; 7.43 to 24.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Epidural Steroid Injection Prior to Cross-Over
	Comments	The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.17
	Confidence Interval	() 95%; -1.24 to 13.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Vertos Mild® Minimally-Invasive Lumbar Decompression		Epidural Steroid Injection		ESI Cross-over to Lumbar Decompression With Mild
Arm/Group Description	Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.		Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use. The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure		Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure
All Cause Mortality
	Vertos Mild® Minimally-Invasive Lumbar Decompression		Epidural Steroid Injection		ESI Cross-over to Lumbar Decompression With Mild
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Vertos Mild® Minimally-Invasive Lumbar Decompression		Epidural Steroid Injection		ESI Cross-over to Lumbar Decompression With Mild
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Vertos Mild® Minimally-Invasive Lumbar Decompression		Epidural Steroid Injection		ESI Cross-over to Lumbar Decompression With Mild
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/17 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.