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OpenTrials
Completed

NCT Number: NCT03699891

Evaluation of the Fortilink IBF System With TETRAfuse Technology

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

Completed

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Key information

Conditions

Cervical and Lumbar Fusion

Sex eligibility

All sexes

Study type

Observational

Primary location

Los Angeles Orthopedic Institute, Sherman Oaks, California, United States

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About this study

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

The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must have had an attempted implant of the Fortilink IBF System

Exclusion criteria

  • There are no exclusion criteria

Treatment and study plan

Fortilink IBF System with TETRAfuse Technology

Device

Cervical and lumbar fusion

Primary outcomes

  1. Safety outcomes associated with use of the Fortlink System

    Time frame: Up to 1 year

    Safety assessment includes evaluation of all adverse events or complications related to the procedure and post-operative adverse events.

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Acronym: ENTRUST

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Oct 2, 2019

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.