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.
Study Type
OBSERVATIONAL
Enrollment
129
All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.
Pain Medicine Associates
Fountain Valley, California, United States
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
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California Orthopedics & Spine
Larkspur, California, United States
Relieve Pain Center, Inc.
San Diego, California, United States
Source Healthcare
Santa Monica, California, United States
Pacific Research Institute
Santa Rosa, California, United States
IPM Medical Group Inc
Walnut Creek, California, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
Louis J. Raso, MD, PA
Jupiter, Florida, United States
Florida Pain Institute
Merritt Island, Florida, United States
Southwest Florida Pain Center
Port Charlotte, Florida, United States
...and 13 more locations