Klaus John Schnake1, Nikolai Fleiter2, Christoph Hoffmann3, Andreas Pingel3, Matti Scholz3, Alexander Langheinrich4, Frank Kandziora3. 1. Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien, Rathsberger Strasse 57, 91054, Erlangen, Germany. klaus.schnake@waldkrankenhaus.de. 2. Orthopaedicum Frankfurt, Frankfurt am Main, Germany. 3. Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany. 4. Department of Diagnostic and Interventional Radiology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany.
Abstract
PURPOSE: This study aimed to compare clinical results and fusion rates of uncoated polyetheretherketone (PEEK) cages with titanium-coated PEEK cages in posterior lumbar interbody fusion (PLIF) surgery. METHODS: A prospective randomised study including 60 patients with one- or two-segment lumbar degenerative diseases. Patients received either titanium-coated PEEK cages (group A) or uncoated PEEK cages (group B). Fusion rates were evaluated on plain X-rays and CT scans after 6 and 12 months. Clinical follow-up (visual analogue scale, VAS; Oswestry Disability Index score, ODI; EQ-5D) was performed for 24 months. RESULTS:Fifty-five patients (92%) (36 female, 19 male) had a complete follow-up. There were no statistically significant differences in demographic, peri- or intraoperative data between groups A and B. ODI, VAS and EQ-5D improved significantly (p < 0.001) after surgery without statistically significant differences between the two groups. Overall, 65 operated segments could be evaluated for fusion (group A: 29 segments, group B: 36 segments, p = 0.6). Osseous integration of the cage surface improved significantly (p < 0.001) in both groups between 6 and 12 months after surgery. At 12-month follow-up, neither radiolucency nor signs of instability or dislocation were noted. Fusion was present in CT scans as follows: (a) bone growth through cage pores (A: 100%, B: 100%); (b) bone growth outside the cages (A: 48%, B: 61%; p = 0.3). CONCLUSIONS: PEEK and titanium-coated PEEK cages for PLIF produce equally favourable clinical and radiological results up to 24 months post-surgery. The fusion rate was not different.
RCT Entities:
PURPOSE: This study aimed to compare clinical results and fusion rates of uncoated polyetheretherketone (PEEK) cages with titanium-coated PEEK cages in posterior lumbar interbody fusion (PLIF) surgery. METHODS: A prospective randomised study including 60 patients with one- or two-segment lumbar degenerative diseases. Patients received either titanium-coated PEEK cages (group A) or uncoated PEEK cages (group B). Fusion rates were evaluated on plain X-rays and CT scans after 6 and 12 months. Clinical follow-up (visual analogue scale, VAS; Oswestry Disability Index score, ODI; EQ-5D) was performed for 24 months. RESULTS: Fifty-five patients (92%) (36 female, 19 male) had a complete follow-up. There were no statistically significant differences in demographic, peri- or intraoperative data between groups A and B. ODI, VAS and EQ-5D improved significantly (p < 0.001) after surgery without statistically significant differences between the two groups. Overall, 65 operated segments could be evaluated for fusion (group A: 29 segments, group B: 36 segments, p = 0.6). Osseous integration of the cage surface improved significantly (p < 0.001) in both groups between 6 and 12 months after surgery. At 12-month follow-up, neither radiolucency nor signs of instability or dislocation were noted. Fusion was present in CT scans as follows: (a) bone growth through cage pores (A: 100%, B: 100%); (b) bone growth outside the cages (A: 48%, B: 61%; p = 0.3). CONCLUSIONS: PEEK and titanium-coated PEEK cages for PLIF produce equally favourable clinical and radiological results up to 24 months post-surgery. The fusion rate was not different.