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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-06

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Spinal Stenosis Occipito-Atlanto-Axial Spinal Disease Spinal Stenosis Cervical Spinal Stenosis Cervicothoracic Region Spinal Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Streamline Occipito-Cervico-Thoracic Spinal Fixation System

Spinal Fixation

Intervention Type DEVICE

Other Intervention Names

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Streamline OCT

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Las Vegas Neurosurgical Institute

Las Vegas, Nevada, United States

Site Status

Spine Nevada

Reno, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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1108-CL

Identifier Type: -

Identifier Source: org_study_id