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

RTI Surgical

Status: Completed

Conditions: Cervical and Lumbar Fusion

Treatments: Device: Fortilink IBF System with TETRAfuse Technology

Study type: Observational

Funder types: Industry

Identifiers

NCT03699891

CL1103

Details and patient eligibility

About

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

Full 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.

Enrollment: 119 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• There are no exclusion criteria