Trial Outcomes & Findings for Postmarket Registry for Evaluation of the Superion® Spacer (NCT NCT04087811)

NCT ID: NCT04087811

Last Updated: 2023-07-06

Results Overview

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%.

• Recruitment status: COMPLETED
• Target enrollment: 1674 participants
• Primary outcome timeframe: 3 Week Follow-Up Visit
• Results posted on: 2023-07-06

Participant Flow

Participant milestones

Measure	Superion® Indirect Decompression System (IDS) Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant)
Overall Study STARTED	1674
Overall Study COMPLETED	1594
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was missing for 5 participants. Data as available for study participants is reported.

Baseline characteristics by cohort

Measure	Superion® Indirect Decompression System (IDS) n=1601 Participants Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant)
Age, Continuous	73.1 years STANDARD_DEVIATION 8.4 • n=1596 Participants • Data was missing for 5 participants. Data as available for study participants is reported.
Sex: Female, Male Female	874 Participants n=1601 Participants
Sex: Female, Male Male	727 Participants n=1601 Participants
Baseline Pain Score	68.6 units on a scale STANDARD_DEVIATION 26.1 • n=1432 Participants • Data is missing for 169 participants. Data as available for study participants is reported.

PRIMARY outcome

Timeframe: 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%.

Outcome measures

Measure	Superion® Indirect Decompression System (IDS) n=1311 Participants Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant)
Vertiflex® Patient Satisfaction Survey	1147 Participants

PRIMARY outcome

Timeframe: 6 Month 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%.

Outcome measures

Measure	Superion® Indirect Decompression System (IDS) n=980 Participants Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant)
Vertiflex® Patient Satisfaction Survey	806 Participants

PRIMARY outcome

Timeframe: 12 Month 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%.

Outcome measures

Measure	Superion® Indirect Decompression System (IDS) n=763 Participants Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant)
Vertiflex® Patient Satisfaction Survey	630 Participants

Adverse Events

Superion® Indirect Decompression System (IDS)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Superion® Indirect Decompression System (IDS) n=1674 participants at risk Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant)
Cardiac disorders Atrial Fibrillation	0.06% 1/1674 • Number of events 1 • Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected. Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Respiratory, thoracic and mediastinal disorders Atelectasis (Post-Op)	0.06% 1/1674 • Number of events 1 • Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected. Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Nervous system disorders Headache	0.06% 1/1674 • Number of events 1 • Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected. Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Cardiac disorders Cardiac Arrest	0.12% 2/1674 • Number of events 2 • Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected. Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Cardiac disorders Bradycardia	0.06% 1/1674 • Number of events 1 • Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected. Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Nervous system disorders Pain	0.06% 1/1674 • Number of events 1 • Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected. Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.

Other adverse events

Adverse event data not reported

Additional Information

Roshini Jain, Sr. Director Clinical Sciences

Boston Scientific

Phone: 16619494350

Email: roshini.jain@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place