Trial Outcomes & Findings for Postmarket Outcomes Study for Evaluation of the Superion™ Spacer (NCT NCT04563793)
NCT ID: NCT04563793
Last Updated: 2025-01-13
Results Overview
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)
Recruitment status
COMPLETED
Target enrollment
129 participants
Primary outcome timeframe
Up to 3 years post-procedure
Results posted on
2025-01-13
Participant Flow
Participant milestones
| Measure |
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.
Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure.
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|---|---|
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Overall Study
STARTED
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129
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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106
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Baseline characteristics by cohort
| Measure |
Superion™ IDS
n=127 Participants
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.
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|---|---|
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Age, Continuous
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72.8 years
STANDARD_DEVIATION 8.6 • n=5 Participants
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Sex: Female, Male
Female
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62 Participants
n=5 Participants
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Sex: Female, Male
Male
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65 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska native
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Black, of African heritage
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5 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
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104 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Other
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Not disclosed
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6 Participants
n=5 Participants
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Region of Enrollment
United States
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127 participants
n=5 Participants
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Low Back pain/symptoms
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124 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 3 years post-procedurePopulation: 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.
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)
Outcome measures
| Measure |
Superion™ IDS 6-Month Follow-up
n=30 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.
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Superion™ IDS 1-Year Follow-up
n=11 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.
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Superion™ IDS 2-Year Follow-up
n=8 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.
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Superion™ IDS 3-Year Follow-up
n=7 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.
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Low Back Pain Responder Rate
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17 Participants
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3 Participants
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1 Participants
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2 Participants
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PRIMARY outcome
Timeframe: Up to 3 years post-procedurePopulation: 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.
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)
Outcome measures
| Measure |
Superion™ IDS 6-Month Follow-up
n=23 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.
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Superion™ IDS 1-Year Follow-up
n=9 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.
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Superion™ IDS 2-Year Follow-up
n=4 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.
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Superion™ IDS 3-Year Follow-up
n=5 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.
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Left Leg Pain Responder Rate
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15 Participants
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7 Participants
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2 Participants
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0 Participants
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PRIMARY outcome
Timeframe: Up to 3 years post-procedurePopulation: 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.
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)
Outcome measures
| Measure |
Superion™ IDS 6-Month Follow-up
n=25 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.
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Superion™ IDS 1-Year Follow-up
n=10 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.
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Superion™ IDS 2-Year Follow-up
n=7 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.
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Superion™ IDS 3-Year Follow-up
n=6 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.
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Right Leg Pain Responder Rate
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18 Participants
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6 Participants
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3 Participants
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 years post-procedurePopulation: 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.
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%.
Outcome measures
| Measure |
Superion™ IDS 6-Month Follow-up
n=33 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.
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Superion™ IDS 1-Year Follow-up
n=10 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.
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Superion™ IDS 2-Year Follow-up
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.
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Superion™ IDS 3-Year Follow-up
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.
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Percent Low Back Pain Relief
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46.7 percentage of low back pain relief
Standard Deviation 37.4
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58.3 percentage of low back pain relief
Standard Deviation 42.2
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—
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 years post-procedurePopulation: 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.
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.
Outcome measures
| Measure |
Superion™ IDS 6-Month Follow-up
n=34 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 6-Month Visit.
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Superion™ IDS 1-Year Follow-up
n=12 Participants
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit.
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Superion™ IDS 2-Year Follow-up
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 2-Year Visit.
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Superion™ IDS 3-Year Follow-up
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit.
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Quality of Life (QoL)
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65.6 percent change of score on a scale
Standard Deviation 89.2
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47.8 percent change of score on a scale
Standard Deviation 44.6
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—
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—
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Adverse Events
Superion™ IDS
Serious events: 12 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Superion™ IDS
n=129 participants at risk
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.
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Injury, poisoning and procedural complications
Spinal Fracture
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0.78%
1/129 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Cardiac disorders
Acute coronary syndrome
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Infections and infestations
COVID-19 pneumonia
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1.6%
2/129 • Number of events 2 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Infections and infestations
Pneumocystis jirovecii pneumonia
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Musculoskeletal and connective tissue disorders
Osteonecrosis
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Nervous system disorders
Encephalopathy
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
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1.6%
2/129 • Number of events 2 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Surgical and medical procedures
Spinal operation
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Vascular disorders
Deep Vein thrombosis
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Gastrointestinal disorders
Colitis ulcerative
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Other adverse events
| Measure |
Superion™ IDS
n=129 participants at risk
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.
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|---|---|
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Infections and infestations
Purulent discharge
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Injury, poisoning and procedural complications
Incision site haematoma
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Musculoskeletal and connective tissue disorders
Back Pain
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0.78%
1/129 • Number of events 1 • From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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Additional Information
Sr. Director, Clinical Operations
Boston Scientific Corporation
Phone: 855-213-9890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place