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Evaluation of the Fortilink IBF System With TETRAfuse Technology (ENTRUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699891
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

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

Condition or disease Intervention/treatment
Cervical and Lumbar Fusion Device: Fortilink IBF System with TETRAfuse Technology

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Fortilink IBF System With TETRAfuse Technology
Actual Study Start Date : November 6, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019
Groups and Cohorts
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Intervention Details:
  • Device: Fortilink IBF System with TETRAfuse Technology
    Cervical and lumbar fusion

Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient must have had an attempted implant of the Fortilink IBF System
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • There are no exclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699891


Locations
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United States, California
Los Angeles Orthopedic Institute
Sherman Oaks, California, United States, 91403
United States, Colorado
Rocky Mountain Spine
Lone Tree, Colorado, United States, 80124
United States, Florida
Florida Back Institute
Boca Raton, Florida, United States, 33496
Spine Institute of South Florida
Delray Beach, Florida, United States, 33484
United States, Maryland
OrthoBethesda
Bethesda, Maryland, United States, 20817
Sponsors and Collaborators
RTI Surgical
More Information
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Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT03699891    
Other Study ID Numbers: CL1103
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No