PURPOSE:Total cervical artificial disc replacement (TDR) simulates normal disc structure, thus avoiding the drawbacks of anterior cervical decompression and fusion (ACDF). This prospective, randomized, controlled and multicentre study aimed to evaluate clinical and radiographic outcomes by comparing cervical disc replacement using Mobi-C disc prostheses with ACDF. METHODS: This prospective, randomized, controlled and multicentre study consisted of 111 patients undergoing single-level Mobi-C disc prosthesis replacement (TDR group, n = 55) or ACDF (n = 56) from February 2008 to November 2009 at 11 medical centres across China. Patients were assessed before surgery, at seven days postoperation and one, three, six, 12, 24, 36 and 48 months postoperation. Clinical and neurological outcome was determined by measuring the Japanese Orthopaedic Association (JOA) scores, visual analogue scale (VAS) and Neck Disability Index (NDI). Static and dynamic radiographs were obtained of the cervical curvature, the functional spinal unit (FSU) angle and range of motion (ROM) of the cervical spine, FSU angle and treated and adjacent segments. RESULTS:A total of 111 patients were included and randomly assigned to either Mobi-C disc prosthesis replacement or ACDF. JOA, VAS and NDI showed statistically significant improvements 48 months after surgery (P < 0.05). ROM, FSU angle, treated segment and adjacent segments in the Mobi-C group were not significantly different before and after replacement (p > 0.05). ROM in the ACDF group was significantly reduced at one month and remained so throughout the follow-up. By 48-months, more ACDF patients required secondary surgery (four of 56 patients). CONCLUSIONS: Although ACDF may increase the risk of additional surgery, clinical outcomes indicated that both Mobi-C artificial cervical disc replacement and ACDF were reliable. Radiographic data showed that ROM of the cervical spine, FSU angle and treated and adjacent segments were relatively better reconstructed and maintained in the Mobi-C group compared with those in the ACDF group.
RCT Entities:
PURPOSE: Total cervical artificial disc replacement (TDR) simulates normal disc structure, thus avoiding the drawbacks of anterior cervical decompression and fusion (ACDF). This prospective, randomized, controlled and multicentre study aimed to evaluate clinical and radiographic outcomes by comparing cervical disc replacement using Mobi-C disc prostheses with ACDF. METHODS: This prospective, randomized, controlled and multicentre study consisted of 111 patients undergoing single-level Mobi-C disc prosthesis replacement (TDR group, n = 55) or ACDF (n = 56) from February 2008 to November 2009 at 11 medical centres across China. Patients were assessed before surgery, at seven days postoperation and one, three, six, 12, 24, 36 and 48 months postoperation. Clinical and neurological outcome was determined by measuring the Japanese Orthopaedic Association (JOA) scores, visual analogue scale (VAS) and Neck Disability Index (NDI). Static and dynamic radiographs were obtained of the cervical curvature, the functional spinal unit (FSU) angle and range of motion (ROM) of the cervical spine, FSU angle and treated and adjacent segments. RESULTS: A total of 111 patients were included and randomly assigned to either Mobi-C disc prosthesis replacement or ACDF. JOA, VAS and NDI showed statistically significant improvements 48 months after surgery (P < 0.05). ROM, FSU angle, treated segment and adjacent segments in the Mobi-C group were not significantly different before and after replacement (p > 0.05). ROM in the ACDF group was significantly reduced at one month and remained so throughout the follow-up. By 48-months, more ACDFpatients required secondary surgery (four of 56 patients). CONCLUSIONS: Although ACDF may increase the risk of additional surgery, clinical outcomes indicated that both Mobi-C artificial cervical disc replacement and ACDF were reliable. Radiographic data showed that ROM of the cervical spine, FSU angle and treated and adjacent segments were relatively better reconstructed and maintained in the Mobi-C group compared with those in the ACDF group.
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