A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
• Aged 18 years of age or older.
• Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1.
• Have discogenic back pain.
• Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
• Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
• Completed at least 6 months of conservative non-operative treatment.
• Female subjects of childbearing age must have a negative pregnancy test.
• Able to understand this clinical study, co-operate with procedures.
• Able to give voluntary, written informed consent to participate.