Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)

Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)

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

Study Overview

• Status: Completed
• Conditions: Spinal Disease; Spinal Instability; Spinal Stenosis Occipito-Atlanto-Axial; Spinal Stenosis Cervical; Spinal Stenosis Cervicothoracic Region
• Intervention / Treatment: Device: Streamline Occipito-Cervico-Thoracic Spinal Fixation 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Las Vegas Neurosurgical Institute
    • Reno, Nevada, United States, 89521
      • Spine Nevada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects implanted with the OCT System.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate time to demonstration of fusion.	Evaluate time to demonstration of fusion.	12 months

Collaborators and Investigators

• Sponsor: RTI Surgical

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Constriction, Pathologic; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: 1108-CL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No