Porous titanium cervical interbody fusion device in the treatment of degenerative cervical radiculopathy; 1-year results of a prospective controlled trial.

Abstract Background Context Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, PEEK with (auto)graft is frequently used for interbody fusion although alternative implant technology like 3-D printing titanium has been introduced recently. Purpose Reporting the clinical and quantitative radiological outcome of a prospective cohort of 3-D printed porous titanium implants. Study Design/Setting Prospective study of patients with single level ACDF using 3-D printed porous titanium cervical implants. These data were compared to 48 patients from the PEEK with autograft group of the previously performed CASCADE trial. Patient Sample 49 patients were included. Outcome Measures NDI, VAS, self-reported perceived recovery, and fusion status. Methods The clinical outcomes and fusion rates were documented at 3, 6, and 12 months. Dynamic X-rays were analyzed to determine range of motion (RoM) of the operated level. Fusion was defined as rotation ≤ 4° and ≤ 1.25 mm translation on flexion–extension films. Results The mean NDI improved from 41.2 preoperatively to 19.4 at 12 months postoperatively. Both VAS arm and VAS neck improved significantly after surgery and 77.1% of the patients reported complete or nearly complete recovery at 12 months. The mean RoM of the affected disc level decreased from 8.7° (range 2.6 – 21.4) before surgery to 1.6° (0.0 – 4.6°) after 12 months. The fusion rate at 3, 6 and 12 months was 84%, 89%, and 91% respectively, compared to 67%, 72%, and 90%, in the PEEK group. Conclusions 3-D printed porous titanium cervical implants resulted in significant clinical improvement after surgery. The fusion rate of porous titanium compared to PEEK with autograft at 12 months was similar, although porous titanium resulted in faster consolidation. In addition, one level anterior cervical fusion can be successfully achieved without additional plating.