Next-generation artificial cervical disc yielded promising results in patients with cervical radiculopathy
ORLANDO, Fla. — At 2-year follow-up, promising results were seen in patients with cervical radiculopathy implanted with a next-generation artificial cervical disc, according to data presented here.
“[This] study shows excellent clinical and radiographic outcomes for one-level cervical radiculopathy using this M6-C (Spinal Kinetics) arthroplasty,” Rick C. Sasso, MD, said during his presentation at the North American Spine Society Annual Meeting. “But obviously, the entire study cohort is going to be necessary to confirm the safety and efficacy of this device.”
Sasso and colleagues performed a prospective multicenter study of 83 patients with cervical radiculopathy implanted with a M6-C artificial cervical disc at one-level from C3-C7 after no improvements were seen 6 weeks after conservative treatment. Patients were evaluated with the neck disability index (NDI), neck and arm VAS, neurological assessments and radiographic assessments.
Results showed the mean blood loss was 31 cc. The mean surgical time was 83 minutes. Investigators noted 98% of patients needed their posterior longitudinal ligament released during surgery. Patients stayed at the hospital for a mean of 0.5 days. Investigators found mean preoperative NDI was 55.4, which significantly decreased after 2 years to 13.6. The VAS neck pain decreased from 7.3 to 1.4. The mean VAS arm pain in the predominant arm improved from 7.2 preoperatively to 0.3.
Radiographic assessment results showed no radiolucencies or migrations. No cases of neurological deterioration were seen following the procedure. Minimal caudal subsidence was seen in two patients. The index disc level improved preoperatively to 2 years from 1.8° to 7.4°.
“[There] was one reoperation at 1 month due to incomplete decompression,” Sasso said. “This highlights the importance of a good neurological decompression when we are using motion-sparing devices.”–by Monica Jaramillo
Sasso RC, et al. Paper #125. Presented at: North American Spine Society Annual Meeting; Oct. 25-28, 2017; Orlando, Fla.
Disclosure : Sasso reports he receives royalties from Medtronic; is on the board of directors for the Cervical Spine Research Society; and receives research support from Medtronic, Cerapedics and Smith & Nephew.