Similar outcomes with Kineflex-L and CHARITE lumbar total disc replacements

1. The rates of success, patient satisfaction, device-related complications, and reoperation were similar between Kineflex-L Disc and CHARITE. 

2. There were no significant differences between Kineflex-L Disc and CHARITE with regard to operative time, blood loss, or length of hospital stay. 

Evidence Rating Level: 2 (Good)            

Study Rundown: Lumbar total disc replacement (TDR) is a relatively new treatment option patients suffering from symptomatic disc degeneration who do not respond to non-operative care. Despite the growing publications showing the efficacy of individual devices, the literature comparing various TDR devices is limited. In this study, patients with single-level symptomatic disc degeneration who were treated non-operatively for at least 6 months were assigned to either the investigational group (Kineflex-L Disc; metal-on-metal design anchored with keels) or the control group (CHARITE artificial disc; metal with polyethylene core with teeth for anchoring). The authors found that there were no significant differences between the two TDR devices with regard to their success rates, patient satisfaction, device-related complications, and reoperations. An important strength of this study is the randomized, controlled, multicenter study design with 24-month follow-up. However, a limitation is that not all patients were randomized in this trial. Nonetheless, this study is the first to directly compare two TDR devices and suggest that both Kineflex-L Disc and CHARITE produce equally effective clinical outcomes.

Click to read the study in Spine

Relevant Reading: Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature

In-Depth [randomized controlled trial]: This is a prospective, randomized, controlled, multicenter study involving 457 patients from 21 sites across the United States. All included patients suffered from single-level disc degeneration at either L4-L5 or L5-S1 for at least six months and did not respond to non-operative care. 261 patients (204 randomized and 57 non-randomized) received the Kineflex-L Disc while 196 patients (190 randomized and 6 non-randomized) received the CHARITE artificial disc. The Oswestry Disability Index questionnaire and a visual analog scale for pain and satisfaction were the primary outcome measures.  All outcome measures were compared using the intention-to-treat principle. There were no significant differences between the two TDR devices with regard to operative time, blood loss, or length of hospital stay. In addition, the rates of success (68.1% Kineflex-L Disc vs. 67.4% CHARITE), patient satisfaction (94.1% Kineflex-L Disc vs. 91.9% CHARITE), device-related complications (6.4% Kineflex-L Disc vs. 5.8% CHARITE), and reoperation (10.3% Kineflex-L Disc vs. 8.4% CHARITE) were similar between the two groups.

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