PEEK Cages in Lumbar Fusion Mid-term Clinical Outcome and Radiologic Fusion

Study Design: Historical cohort analysis. Objective: Evaluation of mid-term clinical outcome and radiologic fusion in patients treated with a polyetheretherketone (PEEK) cage. Summary of Background Data: Anterior lumbar interbody fusion can be a good alternative in chronic low back pain when conservative treatment fails. Although titanium alloy cages give good fusion rates, disadvantages are the subsidence of the cage in the adjacent vertebrae and problematic radiologic evaluation of fusion. PEEK cages such as the Synfix-LR cage (Synthes, Switzerland) should overcome this. Methods: From December 2004 until August 2007, 95 patients (21 double-level and 74 single-level) with degenerative disk disease from L3-S1 were operated by a single surgeon. The number of reoperations was counted. Radiologic fusion on computed tomography scan was scored with a new scoring system by an independent skeletal radiologist and orthopedic surgeon. Intraobserver agreement and specificity were assessed. Clinical improvement was measured by the Oswestry Disability Index score. The median duration of clinical follow-up was 47.7 months (range 29.9-61.6). Results: In total, 26 patients were reoperated after a median period of 17.6 months (range 6.7-46.9) of the initial surgery. Of the 26 patients, 23 patients (18 single-level and 5 double-level) were reoperated for symptomatic pseudarthrosis. A moderate agreement (kappa = 0.36) and a specificity of 70% and 37% for the radiologist and orthopedic surgeon, respectively, were found for scoring bony bridging. The Oswestry Disability Index score improved after initial surgery; however, reoperated patients reported a significantly lower improvement. Conclusions: A high number of reoperations after an anterior lumbar interbody fusion procedure with the Synfix-LR cage were found, mainly because of symptomatic pseudarthrosis. The absence of posterior fixation in combination with lower stiffness and the hydrophobic characteristics of PEEK probably lead to insufficient initial stability, creating suboptimal conditions for bony bridging, and thus solid fusion. The proposed ease of the evaluation of radiologic fusion could not be supported. Clinicians should be alert on pseudarthrosis when patients treated with the Synfix-LR cage presented with persisted or aggravated complaints.