Randomized controlled trial of posterior lumbar interbody fusion with Ti- And cap-nanocoated polyetheretherketone cages: Comparative study of the 1-year radiological and clinical outcome

Abstract

Background: Polyetheretherketone (PEEK) is a popular material for posterior lumbar interbody fusion (PLIF) cages, although osseointegration remains limited. To optimize PEEK cage characteristics, titanium (Ti) and calcium phosphate (CaP) nanocoatings have been developed with proven mechanical safety. This multicenter randomized controlled trial compared the clinical and radiological outcome parameters of nanocoated and uncoated PEEK cages, up to 1 year after surgery. Methods: Standard open PLIF surgery was performed on 127 patients, randomized in 3 groups: Ti-nanocoated (n ¼ 44), CaP-nanocoated (n ¼ 46), and uncoated PEEK cages (n ¼ 37). Clinical assessments up to 1 year after surgery included visual analogue scales (VASs), Oswestry Disability Index (ODI), and 36-Item Short Form Survey (SF-36). Primary radiological outcome parameters were implant stability and fusion status, assessed by x-ray and computed tomography (CT) scans. Patients, surgeons, and postsurgery analysts were blinded. Results: PLIF surgery with all cage types resulted in significant improvements of clinical outcome parameters, exceeding the minimum clinically important differences. No significant differences in VAS, ODI, or SF-36 scores were found among the 3 groups. One year after the surgery, 65.6% of patients with uncoated PEEK cages achieved definite fusion. Significantly more patients with nanocoated PEEK cages achieved definite fusion: 93.9% for Ti nanocoating (P ¼ .0034) and 88.0% for CaP nanocoating (P ¼ .032). No significant differences in fusion were found between the nanocoated cage types (P ¼ .4318). Conclusions: The similar clinical outcome improvements after 1 year suggest that nanocoated PEEK cages have the same safety and efficacy as the clinically accepted uncoated PEEK cages. Furthermore, nanocoated PEEK cages achieved a better fusion rate than uncoated PEEK cages at the 1-year follow-up. A 5-year follow-up study is warranted to revisit the findings. Clinical Relevance: The safety, efficacy, and enhanced osseointegration of nanocoated PEEK cages were demonstrated. Osseointegration is a significant predictor of positive long-term clinical outcomes and improved implant longevity, implying a clinical added value of nanocoatings. Enhanced osseointegration becomes even more important in minimally invasive spine surgery and in patients at risk for incomplete fusion.