RTI Surgical enrolled the first patient in a clinical evaluation of the Fortilink® interbody fusion device in the treatment of degenerative disc disease.
The study, named FORTE, is a prospective, postmarket evaluation of the safety and performance of the Fortilink-C, -TS, and -L Interbody Fusion systems made with TETRAfuse® 3D printed polymer material. Its primary objective is to assess radiographic evidence of fusion at three months (Fortilink-C IBF) or six months post-op (Fortilink-TS and Fortilink-L IBF).
The FORTE study will collect and evaluate real world data on adult subjects, exploring pain reduction and procedural and long-term performance. The multicenter study will include 150 patients at up to 20 sites in the U.S. over the next 3.5 years, with post-procedure evaluations post-procedurally at intervals throughout 24 months for study data collection. All subjects are expected to be enrolled in 1Q20.
RTI launched the cervical device in 2017; lumbar versions were released in 2018.
Sources: RTI Surgical, Inc.; ORTHOWORLD Inc.