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

October 23, 2020 updated by: RTI Surgical

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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