Surgical implant developer RTI Surgical has started patient enrolment in the FORTE clinical study to evaluate its Fortilink-C, -TS and -L Interbody Fusion (IBF) systems.
The Fortilink-C IBF system is designed to help increase the fusion potential in anterior cervical discectomy and fusion (ACDF) surgery, while Fortilink-TS and Fortilink-L IBF systems are for posterior spine fusion.
All the three systems feature TETRAfuse 3D Technology, which is an IBF device material meant to aid in optimal outcomes for patients undergoing spinal fusion.
The prospective, multi-centre post-market FORTE study is intended to assess the safety and performance of these devices.
The primary objective of the study is to evaluate radiographic evidence of cervical and lumbar fusion at three-months post-surgery for Fortilink-C IBF System, and six-months post-surgery in case of Fortilink-TS and Fortilink-L IBF systems.
The study aims to capture and analyse real-world data from adults with degenerative disc disease (DDD) in order to assess pain reduction, as well as the procedural and long-term performance of the devices.
It is set to enrol a total of approximately 150 subjects at up to 20 centres in the US over 3.5 years.
RTI Surgical president and CEO Camille Farhat said: “The FORTE study aims to reinforce physician confidence and expand access for patients by showing improved outcomes for appropriate DDD patients based on the unique properties of TETRAfuse 3D Technology.
“We believe TETRAfuse represents a new frontier in spine surgery with its design to participate in fusion, and its bone-like mechanical properties, radiolucency and antibacterial characteristics.”
The company believes that the Fortilink series, which is part of its spine portfolio, has the potential to drive its growth.
Last November, RTI Surgical signed an agreement to further bolster its spinal offering with the acquisition of implant technology company Paradigm Spine.