Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Device: Superion™ IDS

• Registration Number: NCT04563793
• Lead Sponsor: Boston Scientific Corporation

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 Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-24
• Study Start: 2020-10-08
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Results First Submitted: 2023-08-16
• Status Verified: 2024-09
• Results First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Results First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Key

Exclusion Criteria

• Meets any contraindication in BSC Indirect Decompression Systems local IFU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Superion™ IDS	Superion™ IDS	All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.

Primary Outcome Measures

Name	Time	Method
Low Back Pain Responder Rate	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	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	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)

Trial Locations

Locations (23)

California Orthopedics & Spine; 🇺🇸 Larkspur, California, United States

Pain Medicine Associates; 🇺🇸 Fountain Valley, California, United States

Source Healthcare; 🇺🇸 Santa Monica, California, United States

Relieve Pain Center, Inc.; 🇺🇸 San Diego, 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

Southwest Florida Pain Center; 🇺🇸 Port Charlotte, Florida, United States

Georgia Pain and Spine Care, Inc.; 🇺🇸 Newnan, Georgia, United States

Florida Pain Institute; 🇺🇸 Merritt Island, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

KC Pain Centers; 🇺🇸 Lee's Summit, Missouri, United States

The Toledo Clinic; 🇺🇸 Toledo, Ohio, United States

Center for Interventional Pain and Spine; 🇺🇸 Bryn Mawr, Pennsylvania, United States

Advanced Spine Pain Solution; 🇺🇸 Laredo, Texas, United States

Precision Spine Care; 🇺🇸 Tyler, Texas, United States

North Idaho Day Surgery LLC; 🇺🇸 Post Falls, Idaho, United States

Comprehensive and Interventional Pain Management LLP; 🇺🇸 Henderson, Nevada, United States

University Clinical Research Center; 🇺🇸 Somerset, New Jersey, United States

Premier Pain Center; 🇺🇸 Shrewsbury, New Jersey, United States

Centurion Spine and Pain Centers; 🇺🇸 Waycross, Georgia, United States

Louis J. Raso, MD, PA; 🇺🇸 Jupiter, Florida, United States