Implantation of an empty polyetheretherketone cage in anterior cervical discectomy and fusion: a prospective randomised controlled study with 2 years follow-up.

PURPOSE: To compare the clinical outcomes, radiographic results and fusion rate of ACDF between empty PEEK cages and PEEK cages packed with β-tricalcium phosphate.

METHODS: Forty-five patients were prospectively enrolled with cervical degenerative disc disease who requiring ACDF with a PEEK cage. 23 patients were randomised to the study group (empty cages) and 22 patients were in the control group (cages filled with β-tricalcium phosphate). Both patient groups were fixed with a cervical locking plate. A CT scan was performed 12 months postoperatively and 24 months if not confirmed fused at 12 months to evaluate the status of fusion. Clinical status was evaluated using the Japanese Orthopaedic Association (JOA) score, the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS).

RESULTS: 46 levels (97.88%) in the study group and 44 levels (97.77%) in the control group were confirmed as fused at 24 months. There was no significant difference between the fusion rates observed in the study and control groups (p = 0.82). There was no significant difference in JOA, ODI, or VAS scores at 24 months follow-up. The results showed that the members of the non-fusion group tended to be older than the individuals in the fusion group at 12 months, but was not significant in statistics.

CONCLUSIONS: Similar fusion rates and clinical outcomes were achieved when using ACDF with PEEK cages and instrumentation, regardless of whether the cage was filled with bone substitute at 24 months follow-up. Fusion rates improved over time and are comparable between both groups. These slides can be retrieved under Electronic Supplementary material.