Orthofix Inc OFIX-5000-001 Manual Do Utilizador
15
Failed Fusion Clinical Trial: Overall Success Rate
100
80
60
40
20
0
67%
19%
% Patients Fused
Consistent Users
Inconsistent Users
The four year success rates for these patients in the open trial, non-operative
salvage phase for all subjects (consistent and inconsistent users combined)
was 39% (n=119) as compared with 57% in this phase of the original clinical
trial (i.e., one year postoperative). Consistent users (n=93) of the device in this
phase had a success rate of 44% after four years. Inconsistent users (n=26) of
the device in this phase had a success rate of 19% after four years.
The reduction in success rates from the time of commercial marketing
compared with those at four years showed a similar percentage decrease
(31%) to those in the randomized double-masked trial. During this four year
period, 6% of the original patients in the open phase were lost to follow-up
and are not reflected in these success rates.
salvage phase for all subjects (consistent and inconsistent users combined)
was 39% (n=119) as compared with 57% in this phase of the original clinical
trial (i.e., one year postoperative). Consistent users (n=93) of the device in this
phase had a success rate of 44% after four years. Inconsistent users (n=26) of
the device in this phase had a success rate of 19% after four years.
The reduction in success rates from the time of commercial marketing
compared with those at four years showed a similar percentage decrease
(31%) to those in the randomized double-masked trial. During this four year
period, 6% of the original patients in the open phase were lost to follow-up
and are not reflected in these success rates.
1
Mooney, V., “A Randomized Double-Blind Prospective Study of the Efficacy of Pulsed Electromagnetic
Field for Interbody Lumbar Fusions”, SPINE, Vol. 15, No. 7, P708, 1990.
2
Simmons, JW, Hayes, MA, Christensen, KD, Dwyer, AP, Koulisis, CW, Kimmich, SJ: “The Effect of
Postoperative Pulsed Electromagnetic Fields on Lumbar Fusion: Open Trial Study”. Presented at the
Annual Meeting of the North American Spine Society, Quebec City, Canada, 2 July 1989.