Interbody Fusion Device in the Treatment of Cervicobrachial Syndrome: A Prospective 5-Year Follow-Up Extension Study of Porous Titanium Cervical Cages

Abstract

Background: To assess long-term clinical and radiological data of porous titanium cervical interbody cages. Methods: We recruited 34 out of 49 patients previously enrolled in the EFFECT trial on 3D printed titanium cages, for 5 years follow-up. Objectives were the evaluation of Neck Disability Index, Visual Analog Scale of arm pain and neck pain, Likert self-reported perceived recovery, EQ-5D, fusion status and subsidence. Fusion was defined as rotation ≤ 4° and ≤ 1.25 mm translation at the index level, using flexion-extension radiograph. Results: All patients had good outcomes in terms of NDI (12.5±15.4), VAS neck pain (23.5±24.1), VAS arm pain (18.7±20.2) and EuroQol (0.77±0.24). 88.6% of the patients experienced complete or nearly complete recovery. NDI improved significantly at 5 years compared to 1 year, all other outcome measures did not significantly differ from the 12 months results. The fusion rate at the index level increased from 91.5% at 12 months to 100% at 5 years. Conclusion: 3D printed stand-alone porous titanium cervical implants are effective in terms of clinical and radiological outcome with 88.6% complete or nearly complete recovery and fusion rate of 100% at 5 years follow-up. Moreover, solid single level anterior cervical fusion can be achieved without additional plating. Trial Registration: The study has been registered in The Netherlands Trial Register (NTR 1289) and approved by the Medical Ethical Committee (NL76079.058.20).