Introduction: The authors present 1-year results in 60 patients with cervical radiculopathy due to spondylosis and stenosis that was treated with a bilateral percutaneous facet implant.
Methods: 60 patients were treated with the DTRAX Facet System in a multicenter prospective single-arm study. Only patients with single-level radiculopathy confirmed by history, physical examination, and in some cases confirmatory nerve blocks were included. Patients were assessed pre and postoperatively with validated outcome questionnaires, CT scans, MRI, and dynamic radiographs. Surgery was percutaneous posterior bilateral facet implants consisting of a screw and expandable washer and iliac crest bone aspirate. Alterations of segmental and overall cervical lordosis, foraminal dimensions, device retention and fusion criteria were assessed for up to 1-year with CT reconstructions and radiographs. Fusion criteria were defined as bridging trabecular bone between the facets, translational motion < 2 mm, and angular motion < 5°.
Results: All patients were followed to 1-year postoperatively. The Neck Disability Index, Short Form-12 version 2, and visual analog scale scores were significantly improved at 2 weeks and remained significantly improved up to 1 year. At the treated level, 93% had intrafacet bridging trabecular bone on CT scans, translational motion was < 2 mm in 100% and angular movement was < 5° in 83% at the 1-year follow-up. There was no significant change in overall cervical lordosis. There was a 1.6° loss of segmental lordosis at the treated level at 1 year that was significant. Foraminal width, volume, and posterior disc height was significantly increased at 6 months and returned to baseline levels at 1 year. There was no significant decrease in foraminal width and height at adjacent levels. There were no reoperations or surgery- or device-related complications, including implant failure or retained hardware.
Conclusions: Results indicate that the DTRAX Facet System is safe and effective for treatment of cervical radiculopathy.
Patient Care: This is a minimally invasive approach to posterior cervical fusion that results in less postoperative morbidities.
Learning Objectives: By the conclusion of this session, participants should be able to discuss in small groups a new method for posterior cervical fusion.