Long-term clinicoradiological outcomes of cervical fusion with polyether ether ketone versus cervical disc arthroplasty in a double-blinded randomized control trial

Abstract

Introduction: In this double-blinded randomized controlled trial, we compare the long-term clinicoradiological effects of anterior cervical discectomy and fusion with polyether ether ketone implant (ACDF with PEEK) versus artificial cervical disc (cervical disc arthroplasty [CDA]) in patients with single and bilevel cervical degenerative disc disease (CDDD). Aims: We aimed to compare the pain scores, cervical kinematics, and radiological outcomes in patients undergoing CDA and ACDF for single and bilevel CDDD over 5 years. Settings and Design: This study was carried out from 2010 to 2019 in the Neurosurgery Department of a Tertiary Care Hospital attached to a Medical College in India. Subjects and Methods: We enrolled 30 patients in each group. Clinical and radiological assessments were carried out for all patients over a period of 5 years. Statistical Analysis Used: Wilcoxon Signed-rank test, Mann–Whitney U-test, and Fischer's exact test were used for comparing the preoperative and follow-uP values. R software version 3.6.0 was used for statistical analysis. Results: A significant improvement in the cervical range of motion, sagittal range of motion (ROM), and functional spinal unit (FSU) was observed in the CDA group at final follow-up, while the PEEK group reported a significant decrease in the ROM and FSU and the difference between the two groups was also found to be statistically significant. Conclusions: When assessed over 5 years following surgery, we found CDA to be superior with respect to ROM, FSU, overall cervical alignment, and maintenance of disc height when compared to ACDF with PEEK implant.