Report in English with a French summary - KCE

KCE reports vol.39 Spine technology 9
Two interventional subjects and one control subject required removal of their implant.
This is a major concern particularly at the L5S1-level because of the neighbouring
anatomical structures. However, no hard safety data exist about implant removal.
The interventional group also experienced more superficial wound infection (6.3% vs.
2.0% in the control group) (figure 3). However, in the control group 18.2% reported
pain at the donor graft site, and 9.1% had pseudo-arthrosis.
Review: Intervertebral disk replacement
Comparison: 02 Charité disk vs. ALIF BAK cage
Outcome: 01 Device-related adverse events
Study Treatment Control OR (fixed) Weight OR (fixed)
or sub-category n/N n/N 95% CI % 95% CI
Blumenthal 16/205 4/99 100.00 2.01 [0.65, 6.18]
Total (95% CI) 205 99 100.00 2.01 [0.65, 6.18]
Total events: 16 (Treatment), 4 (Control)
Test for heterogeneity: not applicable
Test for overall effect: Z = 1.22 (P = 0.22)
Review: Intervertebral disk replacement
Comparison: 02 Charité disk vs. ALIF BAK cage
Outcome: 02 Superficial wound infection
0.01 0.1 1 10 100
Favours treatment Favours control
Study Treatment Control OR (fixed) Weight OR (fixed)
or sub-category n/N n/N 95% CI % 95% CI
Blumenthal 13/205 2/99 100.00 3.28 [0.73, 14.84]
Total (95% CI) 205 99 100.00 3.28 [0.73, 14.84]
Total events: 13 (Treatment), 2 (Control)
Test for heterogeneity: not applicable
Test for overall effect: Z = 1.54 (P = 0.12)
Review: Intervertebral disk replacement
Comparison: 02 Charité disk vs. ALIF BAK cage
Outcome: 03 Device failure
0.01 0.1 1 10 100
Favours treatment Favours control
Study Treatment Control OR (fixed) Weight OR (fixed)
or sub-category n/N n/N 95% CI % 95% CI
Blumenthal 11/205 8/99 100.00 0.64 [0.25, 1.66]
Total (95% CI) 205 99 100.00 0.64 [0.25, 1.66]
Total events: 11 (Treatment), 8 (Control)
Test for heterogeneity: not applicable
Test for overall effect: Z = 0.91 (P = 0.36)
2.3.1.9 Ongoing trials
0.01 0.1 1 10 100
Favours treatment Favours control
Figure 3 : comparison of adverse events between the Charité disk and ALIF
BAK cage 17, 25, 34 .
Several trials comparing intervertebral disc replacement with spinal fusion are currently
ongoing. In October 2004, the FDA approved the Charité disc based on the 2-year
results of a randomized controlled trial comparing the disc to anterior fusion with the
BAK cage 35 . A post-approval trial is now following implanted patients during 5 years 36 .
In Europe, the RESORD trial is ongoing 8 . The newer devices (Flexicore, Maverick, and
Kineflex) also have ongoing randomized controlled trials 33, 37 .