Kineflex lumbar artificial disc versus Charité lumbar total disc replacement for the treatment of degenerative disc disease: A randomized non-inferiority trial with minimum of 2 years’ follow-up

BACKGROUND: The Kineflex lumbar artificial disc replacement device (SpinalMotion, Mountain View, California) is a semiconstrained, posterior center of rotation, metal-on-metal intervertebral disc prosthesis. We performed a prospective, randomized, non-inferiority trial comparing the Kineflex Disc with the Food and Drug Administration (FDA)–approved Charité device (DePuy Spine, Raynham, Massachusetts). Our objective was to evaluate the Kineflex Disc's safety and efficacy using validated outcomes measures—the visual analog scale (VAS) and the Oswestry Disability Index (ODI). METHODS: Sixty-four patients were randomized to receive either the Kineflex Disc or Charité device and were then followed up for up to 3 years. Patients completed VAS and ODI questionnaires and were evaluated clinically and radiologically for complication or device failure. Results were analyzed in terms of change in mean VAS score and ODI from baseline, as well as with a comparison of clinical success as defined by FDA investigational device exemption criteria. Non-inferiority was defined as a difference of less than 18 points in the VAS score and difference of less than 10 units on the ODI scale, in keeping with a previously established minimum clinically important difference. RESULTS: The mean improvement for the Kineflex Disc group at 24 months was 56.80 for the VAS score and 37.30 for the ODI. Similarly, the mean improvement in the Charité group was 54.43 for the VAS score and 38.40 for the ODI. At 2 years of follow-up, no difference was found in VAS scores between the two groups. The Kineflex Disc group was therefore found to be non-inferior (mean difference, 2.37; 95% confidence interval, −12.5 to 17.3; P = .004). In addition, at 24 months, 83% of patients in the Kineflex Disc group and 85% of patients in the Charité group met FDA-defined criteria for clinical success, with no difference between groups (P = .802). CONCLUSIONS: This level I evidence shows the Kineflex Disc to be non-inferior to the Charité device in terms of pain reduction (VAS score) and FDA-defined clinical success at 24 months’ follow-up. Both devices showed a high degree of safety.