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Completed

NCT Number: NCT04171544

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

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

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Key information

Conditions

Spinal Stenosis Occipito-Atlanto-Axial Bone Diseases Musculoskeletal Diseases Spinal Disease Spinal Diseases Spinal Instability Spinal Stenosis Cervical Spinal Stenosis Cervicothoracic Region

Sex eligibility

All sexes

Study type

Observational

Primary location

Las Vegas Neurosurgical Institute, Las Vegas, Nevada, United States

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria.

Treatment and study plan

Streamline Occipito-Cervico-Thoracic Spinal Fixation System

Device

Spinal Fixation

Other names: Streamline OCT

Primary outcomes

  1. Evaluate time to demonstration of fusion.

    Time frame: 12 months

    Evaluate time to demonstration of fusion.

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Official study title

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

Acronym: OCT PMCF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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