Lumbar Spinal Stenosis
Conditions
Brief summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Detailed description
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.
Interventions
DEVICESuperion™ IDS
All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU) * Signed a valid, IRB approved informed consent form Key
Exclusion criteria
* Meets any contraindication in BSC Indirect Decompression Systems local IFU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain Responder Rate | Up to 3 years post-procedure | Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) |
| Left Leg Pain Responder Rate | Up to 3 years post-procedure | Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) |
| Right Leg Pain Responder Rate | Up to 3 years post-procedure | Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent Low Back Pain Relief | Up to 3 years post-procedure | Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR). PPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%. |
| Quality of Life (QoL) | Up to 3 years post-procedure | Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L. EuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Superion™ IDS All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.
Superion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. | 127 |
| Total | 127 |
Baseline characteristics
| Characteristic | Superion™ IDS |
|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 8.6 |
| Low Back pain/symptoms | 124 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska native | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black, of African heritage | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 104 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Not disclosed | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants |
| Region of Enrollment United States | 127 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 3 / 129 |
| serious Total, serious adverse events | 12 / 129 |
Outcome results
Primary
Left Leg Pain Responder Rate
Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Time frame: Up to 3 years post-procedure
Population: Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).~Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superion™ IDS 6-Month Follow-up | Left Leg Pain Responder Rate | 15 Participants |
| Superion™ IDS 1-Year Follow-up | Left Leg Pain Responder Rate | 7 Participants |
| Superion™ IDS 2-Year Follow-up | Left Leg Pain Responder Rate | 2 Participants |
| Superion™ IDS 3-Year Follow-up | Left Leg Pain Responder Rate | 0 Participants |
Primary
Low Back Pain Responder Rate
Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Time frame: Up to 3 years post-procedure
Population: Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).~Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superion™ IDS 6-Month Follow-up | Low Back Pain Responder Rate | 17 Participants |
| Superion™ IDS 1-Year Follow-up | Low Back Pain Responder Rate | 3 Participants |
| Superion™ IDS 2-Year Follow-up | Low Back Pain Responder Rate | 1 Participants |
| Superion™ IDS 3-Year Follow-up | Low Back Pain Responder Rate | 2 Participants |
Primary
Right Leg Pain Responder Rate
Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Time frame: Up to 3 years post-procedure
Population: Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).~Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superion™ IDS 6-Month Follow-up | Right Leg Pain Responder Rate | 18 Participants |
| Superion™ IDS 1-Year Follow-up | Right Leg Pain Responder Rate | 6 Participants |
| Superion™ IDS 2-Year Follow-up | Right Leg Pain Responder Rate | 3 Participants |
| Superion™ IDS 3-Year Follow-up | Right Leg Pain Responder Rate | 0 Participants |
Other Pre-specified
Percent Low Back Pain Relief
Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR). PPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%.
Time frame: Up to 3 years post-procedure
Population: No patients completed the percent pain relief at 2 and 3-Year Follow-up Visits. Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).~Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superion™ IDS 6-Month Follow-up | Percent Low Back Pain Relief | 46.7 percentage of low back pain relief | Standard Deviation 37.4 |
| Superion™ IDS 1-Year Follow-up | Percent Low Back Pain Relief | 58.3 percentage of low back pain relief | Standard Deviation 42.2 |
Other Pre-specified
Quality of Life (QoL)
Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L. EuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public.
Time frame: Up to 3 years post-procedure
Population: No patients completed EQ5D-5L at 2 and 3 year visits. Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS).~Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superion™ IDS 6-Month Follow-up | Quality of Life (QoL) | 65.6 percent change of score on a scale | Standard Deviation 89.2 |
| Superion™ IDS 1-Year Follow-up | Quality of Life (QoL) | 47.8 percent change of score on a scale | Standard Deviation 44.6 |