Report in English with a French summary - KCE

6 Spine technology KCE reports vol.39
2.3.1.4 Data extraction strategy
2.3.1.5 HTA reports
As for clinical trials, information was captured about the study design, number and type
of patients included, intervention, comparator, outcome variables and results.Results
Eight possible HTA reports were identified. Only two of these the CTAF and the
NICE report were considered as fair quality reports and were included 8, 10 . The
remaining six were graded as poor quality and therefore excluded from further review
11-16 . The quality appraisal of the eight identified HTA reports and the evidence tables of
the two included HTA reports are provided in appendix.
California Technology Assessment Forum HTA report 10
This report focused on intervertebral disk replacement with the SB Charité III disk.
Other devices were not considered because of limited data on clinical outcomes in the
literature. The literature search (through December 2004) revealed four uncontrolled
case series and one randomized controlled trial. This RCT, which was found to have
important methodological flaws 17 , found significantly improved pain and ODI scores
after disk replacement as compared to spinal fusion. On the basis of this weak evidence,
the author of the HTA report concluded that further data were needed in order to
determine whether the SB Charité III disk meets the five technology assessment criteria
of CTAF.
National Institute for Clinical Excellence HTA report 8
This report was based on a rapid review of the published literature by ASERNIP-S 18
and also focused on the SB Charité III disk. An extensive literature search revealed 11
published studies (1 RCT, 1 non-randomized comparative study, and 9 case series) and
one RCT in progress. All studies identified by CTAF 10 (see above) were also found by
NICE. However, the methodological drawbacks of the included RCT 17 were not
discussed in the same detail as CTAF did 10 . The authors concluded in their guidance
that the evidence was adequate to support the use of intervertebral disk replacement.
However, they stressed the need for long-term data and the audit and review of clinical
outcomes of all patients having intervertebral disk replacement.
2.3.1.6 Systematic reviews
Three possible systematic reviews were identified. One Chinese systematic review
could not be assessed because of the unavailability of the full-text 19 , and was not
included. The two other systematic reviews were found to be of fair quality and were
included 20, 21 (see appendix for quality appraisal and evidence table).
The literature search by de Kleuver et al. was thorough, although EMBASE and the grey
literature were not searched 21 . It was performed through January 2002, and could
therefore not identify the RCT of Geisler et al. 17 . Nine articles (all observational
studies) were identified, of which the majority was also identified in the HTA report of
NICE 8 . On the basis of the identified evidence, de Kleuver et al. considered
intervertebral disk replacement an experimental procedure 21 .
The systematic review of the Evidence Based Practice Group (EBPG) had as primary
objective to investigate the safety and effectiveness of intervertebral cervical disk
replacement 20 . Their secondary objective was the identification of reviews or
systematic reviews on artificial vertebral disks in general (including lumbar) through a
non-systematic literature search. However, the search strategy was as thorough as the
one used by de Kleuver et al., and included a search of the websites of INAHTAmembers,
but not EMBASE. Three HTA reports 8, 13, 15 , one systematic review 21 , and
one RCT 17 were identified. Based on the evidence, the EBPG considered intervertebral
disk replacement at an experimental stage.