Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up

Completed

• Conditions: Spinal Stenosis Occipito-Atlanto-Axial; Spinal Stenosis Cervical; Spinal Stenosis Cervicothoracic Region; Spinal Disease; Spinal Instability

• Registration Number: NCT04171544
• Lead Sponsor: RTI Surgical

Brief Summary

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.

Detailed Description

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.

Study Timeline

• Study Start: 2019-08-06
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subject must have had an implant of the OCT System.

Exclusion Criteria

• No exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate time to demonstration of fusion.	12 months	Evaluate time to demonstration of fusion.

Trial Locations

Locations (2)

Las Vegas Neurosurgical Institute; 🇺🇸 Las Vegas, Nevada, United States

Spine Nevada; 🇺🇸 Reno, Nevada, United States