Lumbar Spinal Stenosis
Conditions
Keywords
LSS
Brief summary
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
Detailed description
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.
Interventions
DEVICESuperion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) (Superion® implant)
Sponsors
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female patients ≥45 years of age * symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5 * meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)
Exclusion criteria
* not contraindicated as described in the labeled indications for use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertiflex® Patient Satisfaction Survey | 3 Week Follow-Up Visit | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Superion® Indirect Decompression System (IDS) Superion® Indirect Decompression System (IDS) - Interspinous Spacer
Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant) | 1,601 |
| Total | 1,601 |
Baseline characteristics
| Characteristic | Superion® Indirect Decompression System (IDS) | — |
|---|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 8.4 | — |
| Baseline Pain Score | 68.6 units on a scale STANDARD_DEVIATION 26.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 874 Participants | — |
| Sex: Female, Male Male | 727 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,674 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 5 / 1,674 |
Outcome results
Primary
Vertiflex® Patient Satisfaction Survey
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Time frame: 3 Week Follow-Up Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superion® Indirect Decompression System (IDS) | Vertiflex® Patient Satisfaction Survey | 1147 Participants |
Primary
Vertiflex® Patient Satisfaction Survey
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Time frame: 6 Month Follow-Up Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superion® Indirect Decompression System (IDS) | Vertiflex® Patient Satisfaction Survey | 806 Participants |
Primary
Vertiflex® Patient Satisfaction Survey
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
Time frame: 12 Month Follow-Up Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superion® Indirect Decompression System (IDS) | Vertiflex® Patient Satisfaction Survey | 630 Participants |