Report in English with a French summary - KCE

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40 Spine technology KCE reports vol.39 Table 5 : Systematic reviews Study ID Intervention Quality Assessment Good / Fair Remarks Conclusions/Recommendations de Kleuver 2003 Intervertebral disk replacement Fair Search strategy limited to peer-reviewed The authors concluded that total disk literature (CDRCT, Current Contents, replacement should be considered an Medline, Cinahl); no Embase search. experimental procedure and should only be Possibility of double-counting of results (inclusion of the study of Griffith et al, see remark on page 111). used in strict clinical trials. Martin 2005 Intervertebral disk replacement Fair Primary objective of the SR was to The author expressed his concern on the quality investigate the safety and effectiveness of of the study that formed the basis for the intervertebral cervical disk implants, and approval of the SB Charité III disk by the US to investigate its relative advantage FDA. compared to cervical fusion in treating The author concluded that artificial DDD. The secondary objective of the SR intervertebral disks should be considered still at was to summarize available SRs on artificial disk replacement in general (including lumbar disk replacement). an experimental stage.
KCE reports vol.39 Spine technology 41 Table 6 : Randomized controlled trials Study ID Patients Intervention/comparator Quality Assessment Good / Fair Outcomes Geisler 2004 Patients with single-level symptomatic Intervention: Lumbar total disk Fair VAS score at 2y: IDR 31.2 vs. control 37.5, Blumenthal 2005 DDD at L4-L5 or L5-S1 confirmed by replacement with the Charité disk (n p=0.11 McAfee 2005 provocative discography; failure to = 205) ODI score at 2y: IDR 26.3 vs. control 30.5, respond to nonfusion treatment for a Comparator: ALIF with BAK fusion p=0.27 period of at least 6 months. cage packed with iliac crest autograft Clinical success at 2y: IDR 63.6% vs. control (n = 99) 56.8%, p=0.0004 Equivalent overall complication rate (p=0.68) and device failure (p=0.45)
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