An observational study in Lumbar Spinal Stenosis, sponsored by Boston Scientific Corporation. Completed at 23 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Boston Scientific Corporation · Observational
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
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.
469 studies on the registry are indexed under Spinal Stenosis; 106 are open to participants now.
This study's enrollment of 129 is close to the median of 118 across 156 observational studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with moderate Lumbar Spinal Stenosis
Key Inclusion Criteria:
Key Exclusion Criteria:
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.
Device: Superion™ IDS
All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.
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
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
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
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
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
| Milestone | Superion™ IDS |
|---|---|
| Started | 129 |
| Completed | 23 |
| Not completed | 106 |
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)
| Participants | Superion™ IDS 6-Month Follow-up | Superion™ IDS 1-Year Follow-up | Superion™ IDS 2-Year Follow-up | Superion™ IDS 3-Year Follow-up |
|---|---|---|---|---|
| Low Back Pain Responder Rate | 17 | 3 | 1 | 2 |
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)
| Participants | Superion™ IDS 6-Month Follow-up | Superion™ IDS 1-Year Follow-up | Superion™ IDS 2-Year Follow-up | Superion™ IDS 3-Year Follow-up |
|---|---|---|---|---|
| Left Leg Pain Responder Rate | 15 | 7 | 2 | 0 |
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)
| Participants | Superion™ IDS 6-Month Follow-up | Superion™ IDS 1-Year Follow-up | Superion™ IDS 2-Year Follow-up | Superion™ IDS 3-Year Follow-up |
|---|---|---|---|---|
| Right Leg Pain Responder Rate | 18 | 6 | 3 | 0 |
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%.
| percentage of low back pain relief | Superion™ IDS 6-Month Follow-up | Superion™ IDS 1-Year Follow-up |
|---|---|---|
| Percent Low Back Pain Relief | 46.7 ± 37.4 | 58.3 ± 42.2 |
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.
| percent change of score on a scale | Superion™ IDS 6-Month Follow-up | Superion™ IDS 1-Year Follow-up |
|---|---|---|
| Quality of Life (QoL) | 65.6 ± 89.2 | 47.8 ± 44.6 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Superion™ IDS | 0/129 (0%) | 12/129 (9.3%) | 3/129 (2.3%) |
| Event | Superion™ IDS |
|---|---|
| COVID-19 pneumoniaInfections and infestations | 2/129 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/129 |
| Spinal FractureInjury, poisoning and procedural complications | 1/129 |
| Acute coronary syndromeCardiac disorders | 1/129 |
| Pneumocystis jirovecii pneumoniaInfections and infestations | 1/129 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 1/129 |
| EncephalopathyNervous system disorders | 1/129 |
| Spinal operationSurgical and medical procedures | 1/129 |
| Deep Vein thrombosisVascular disorders | 1/129 |
| Colitis ulcerativeGastrointestinal disorders | 1/129 |
| Event | Superion™ IDS |
|---|---|
| Purulent dischargeInfections and infestations | 1/129 |
| Incision site haematomaInjury, poisoning and procedural complications | 1/129 |
| Back PainMusculoskeletal and connective tissue disorders | 1/129 |
All subjects who completed the baseline information. Two subjects were consented but did not complete the baseline information.
| Age, Continuous(years) | Superion™ IDS |
|---|---|
| Mean | 72.8 ± 8.6 |
| Sex: Female, Male(Participants) | Superion™ IDS |
|---|---|
| Female | 62 |
| Male | 65 |
| Race/Ethnicity, Customized(Participants) | Superion™ IDS |
|---|---|
| Race/Ethnicity — American Indian or Alaska native | 2 |
| Race/Ethnicity — Black, of African heritage | 5 |
| Race/Ethnicity — Caucasian | 104 |
| Race/Ethnicity — Hispanic or Latino | 8 |
| Race/Ethnicity — Other | 2 |
| Race/Ethnicity — Not disclosed | 6 |
| Region of Enrollment(participants) | Superion™ IDS |
|---|---|
| United States | 127 |
| Low Back pain/symptoms(Participants) | Superion™ IDS |
|---|---|
| Count of participants | 124 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boston Scientific Corporation →