Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 129
- Locations
- 23
- Primary Endpoint
- Low Back Pain Responder Rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Meets any contraindication in BSC Indirect Decompression Systems local IFU
Outcomes
Primary Outcomes
Low Back Pain Responder Rate
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported