It was recently announced that RTI Surgical has enrolled the first patient in its “Clinical evaluation of Fortilink interbody fusion device with TETRAfuse 3D technology in subjects with degenerative disc disease“ (FORTE) study.
FORTE is a prospective, multicentre post-market evaluation of the safety and performance of the Fortilink-C, -TS, and -L interbody fusion (IBF) systems with TETRAfuse 3D technology, which recently won a 2018 Orthopedics This Week Spine Technology Award. The primary objective of the study is to assess radiographic evidence of cervical and lumbar fusion evaluated by an independent core laboratory at 3-months post-surgery (Fortilink-C IBF system) or 6-months post-surgery (Fortilink-TS and Fortilink-L IBF systems).
“I’ve really been impressed with the TETRAfuse implants so far,” said K Brandon Strenge, at The Orthopaedic Institute. “I’m excited to see the bone growth showing on the CT scans, unlike the titanium implants out there. The lateral implants have a great variety of lordotic options and sizes to accommodate any situation a surgeon may encounter.”
“While PEEK implants are widely used, data suggest PEEK has minimal characteristics to enhance implant osseointegration,” said Christopher Kepler, at The Rothman Orthopaedic Institute. “The porous Fortilink cages with TETRAfuse 3D Technology have the potential to create a favourable environment for bone growth and are radiolucent. I look for the ongoing FORTE study to introduce surgeons to this product and demonstrate the advantages of Fortilink cages over other cage materials.”
The FORTE study will collect and evaluate real world data on adult subjects with degenerative disc disease (DDD) to explore pain reduction and procedural and long-term performance. The scope of the study is to evaluate 150 patients at up to 20 sites in the USA over the next 3.5 years, with evaluations post-procedurally at intervals of 1,3, 6, 12 and 24 months for the purposes of study data collection. All subjects are anticipated to be enrolled in Q1 2020.
TETRAfuse 3D Technology is an IBF device material that is manufactured under an exclusive license agreement with Oxford Performance Materials (OPM), which grants RTI Surgical an exclusive license to OPM’s technology for spinal applications in the USA.