Long-Term Clinicoradiological Outcomes of Cervical Fusion With Polyether Ether Ketone versus Cervical Disc Arthroplasty in a Double-Blinded Randomized Control Trial

一项双盲随机对照试验比较了聚醚醚酮颈椎融合术与颈椎间盘置换术的长期临床放射学结果

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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.

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