The ROTAIO cervical disc prosthesis (Signus) is a safe and efficient treatment option for those with symptomatic degenerative disc disease and demonstrates highly significant clinical improvement and high overall patient satisfaction with very low revision rates at two-year follow-up. This is according to recent research published in the Global Spine Journal by Steffen Fleck (University Medicine Greifswald, Greifswald, Germany) et al.
The multicentre prospective study aimed to evaluate the clinical outcomes and complications within two years of implantation of the ROTAIO cervical disc prosthesis.
A total of 120 patients (72 female and 48 male), with a median age of 43 years (23–60 years) underwent anterior cervical discectomy and arthroplasty (ACDA) with the ROTAIO device and were prospectively followed for 24 months.
Preoperative complaints were primarily associated with radiculopathy (n=104) or myelopathy (n=16). There were 108 monosegmental and 12 bisegmental procedures including six hybrid constructs.
Clinical outcomes were evaluated at three, 12 and 24 months in 100%, 96% and 77% of the cohort using Visual Analogue Scale (VAS), Neck Disability Index (NDI), Work Limitation Questionnaire (WL-26), Patient`s Satisfaction Index (PSI), SF-36 quality of life questionnaire, Nurick Score, Modified Japanese Orthopaedic Association (mJOA) score, Composite Success Rate, complications, patient’s overall satisfaction and analgesics use.
The study found that there were highly significant clinical improvements, according to NDI and VAS (p<0.0001 [arm]; p<0.001 [neck]; p=0.002 [head]), at all time points. Analgetic use could be reduced in 87.1% to 95.2% and doctor`s visits were found to have reduced in 93.8% of the cohort at 24 months.
Patient’s overall satisfaction was high (78.4%–83.5%) and the composite success rate was 77.5% after 12 months and 76.9% after 24 months. There were no major complications recorded. However, slight subsidence of the prosthesis was observed in two patients and three patients demonstrated fusion after 24 months. Two patients developed symptomatic foraminal stenosis, so that implant removal and fusion was performed resulting in a revision rate of 1.7% within the two-year timeframe.