Trial Outcomes & Findings for The MOTION Study - Treatment of LSS With the MILD Procedure (NCT NCT03610737)
NCT ID: NCT03610737
Last Updated: 2024-10-02
Results Overview
Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
Results posted on
2024-10-02
Participant Flow
Participant milestones
| Measure |
MILD With CMM
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD 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.
Other Name: MILD lumbar decompression
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
CMM Alone
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
|
Overall Study
COMPLETED
|
69
|
69
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
MILD With CMM
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD 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.
Other Name: MILD lumbar decompression
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
CMM Alone
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Not treated
|
5
|
2
|
|
Overall Study
Missed Visit
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MILD With CMM
n=77 Participants
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD 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.
Other Name: MILD lumbar decompression
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
CMM Alone
n=78 Participants
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 7.4 • n=77 Participants
|
66.8 Years
STANDARD_DEVIATION 7.5 • n=78 Participants
|
65.7 Years
STANDARD_DEVIATION 7.4 • n=155 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=77 Participants
|
45 Participants
n=78 Participants
|
89 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=77 Participants
|
33 Participants
n=78 Participants
|
66 Participants
n=155 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Mean Change in Oswestry Disability Index (ODI) baseline to 12 monthPopulation: ODI Outcome Measure Mean Improvement
Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).
Outcome measures
| Measure |
MILD With CMM
n=69 Participants
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD 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.
Other Name: MILD lumbar decompression
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
CMM Alone
n=69 Participants
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
|---|---|---|
|
Mean Change in Oswestry Disability Index (ODI)
|
16.1 score on a scale
Standard Deviation 19.0
|
2.0 score on a scale
Standard Deviation 11.7
|
Adverse Events
MILD With CMM
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
CMM Alone
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MILD With CMM
n=77 participants at risk
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD 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.
Other Name: MILD lumbar decompression
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
CMM Alone
n=78 participants at risk
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
2.6%
2/77 • Number of events 3 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
0.00%
0/78 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
General disorders
General disorders
|
1.3%
1/77 • Number of events 1 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
1.3%
1/78 • Number of events 1 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
Infections and infestations
Infections and infestations
|
2.6%
2/77 • Number of events 2 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
2.6%
2/78 • Number of events 2 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.6%
2/77 • Number of events 2 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
2.6%
2/78 • Number of events 2 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
1.3%
1/77 • Number of events 1 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
0.00%
0/78 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
1.3%
1/77 • Number of events 1 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
0.00%
0/78 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
2.6%
2/77 • Number of events 2 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
2.6%
2/78 • Number of events 2 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
|
Nervous system disorders
Nervous system disorders
|
1.3%
1/77 • Number of events 1 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
1.3%
1/78 • Number of events 1 • 1 Year
Adverse events (AE) possibly related or definitely related to the study procedure will be collected for this study unless the AE is determined to be an SAE. All SAEs will be collected regardless of relationship, or lack thereof, to the study devices/procedures.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place