Trehundratjugotvå patienter (215 Coflex och 107 fusioner) vid 21 olika kliniker i USA deltog under 2006 till 2010 i en studie iscensatt av den amerikanska läkemedelsmyndigheten FDA. Syftet var att utvärdera säkerheten och effektiviteten hos Coflex som interlaminär stabilisator i jämförelse med spinal fusion vid behandling av 1 och 2 nivåer av spinal stenos och degenerativ spondylolistes.
Among the 322 patients enrolled in the study, 150
(99 in the coflex® group, 51 in control group) had
a stable (no increase in slip from extension to
flexion) up to Grade I spondylolisthesis. The average
preoperative slip was approximately 9.2% in both
study groups (p=0.999).
This section presents the overall result of the
spondylolisthesis cohort of patients.
In summary, coflex® stabilized the index level
spondylolisthesis, with no significant increase in
adjacent segment translation. In addition, coflex®
provided superior perioperative benefits and similar
clinical outcome results compared to pedicle screw
fusion. Interestingly, fusion stabilized the index level
translation, but created a statistically significant
increase in adjacent segment translation.
