Artificial cervical disc may be safe, effective for total disc replacement
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Key takeaways:
- An artificial cervical disc improved clinical outcomes vs. anterior cervical discectomy and fusion at 5-year follow-up.
- M6-C also had comparable safety outcomes vs. anterior cervical discectomy and fusion.
Results published in The Spine Journal showed an artificial cervical disc may yield improved clinical outcomes compared with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy.
“At 5-year follow-up, [total disc replacement] TDR with the M6-C device (Spinal Kinetics) clinically outperformed [anterior cervical discectomy and fusion] ACDF in terms of pain relief and physical functioning in appropriately selected patients,” Frank M. Phillips, MD, director of the division of spine surgery at Rush University Medical Center, told Healio. “The TDR patients had maintained cervical motion at 5 years, with similar serious adverse event rates between the two cohorts.”
In a prospective, multicenter clinical trial, Phillips and colleagues categorized 349 patients with one-level symptomatic degenerative cervical radiculopathy to receive either ACDF (n=189) or the M6-C Artificial Cervical Disc (n=160) between May 2014 and June 2016. Outcomes measured included composite clinical success at 60 months; function and pain; physical quality of life; and safety, neurologic and radiographic assessments.
Researchers found an 82.3% and 67% composite clinical success rate at 60-month follow-up among patients in the M6-C group and the ACDF treatment group, respectively. In addition, researchers found more patients in the M6-C group achieved neck or arm pain improvement and maintained or improved their quality of life from baseline to 60 months postoperatively compared with the ACDF group.
At 60 months postoperatively, researchers also found patients treated with the M6-C had significantly lower Neck Disability Index scores compared with patients treated with ACDF.
Researchers found the M6-C Artificial Cervical Disc had comparable safety outcomes and improved radiographic outcomes, including range of motion and disc height, compared with ACDF.
“The results of this study are reflective of excellent outcomes in patients with appropriate indications within the confines of an FDA [investigational device exemption] IDE study,” Phillips told Healio. “Further research will be required to determine if similar safety and effectiveness outcomes are achieved as indications for TDR continue to expand.”
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Phillips FM, et al. Spine J. 2023;doi:10.1016/j.spinee.2023.10.020.
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