[Design and preliminary clinical application of general spine system].
OBJECTIVE
To evaluate the efficacy of self-designed General Spine System (GSS) through the measurement of the biomechanical characteristics and the outcomes of preliminary clinical application.


METHODS
The General Spine System implants were made of titanium alloy (TC4, Ti6Al4V) and the instruments were made of stainless steel after design. Pull-out strength of GSS screw, CCD, SOCON, TSRH and Diapason screw were tested in fresh normal cadaveric spine specimens respecting and the biomechanical stability analyses of GSS and SOCON were also tested. GSS was applied clinically in 16 patients with degenerative lumbar spondylolisthesis combined with lumbar canal stenosis. Clinical efficacy, reduction effectiveness, and complications were recorded.


RESULTS
The pull-out strength of GSS screw was more than other control screws. Biomechanical stability of GSS was similar to SOCON system. Average postoperative follow-up for all patients was 12.6 months (11.5-14.5 months). All patients got satisfied clinical results at the latest follow-up. X-ray results showed complete reduction for all spondylolisthesis patients, and results remained good in follow-up. Complications related to implants or operation were not observed after surgery or in follow-up.


CONCLUSIONS
GSS pedicle screws have strong anchoring ability and good stabilization for spondylolisthesis. This system can provide good reduction for spondylolisthesis. Its clinical efficacy is confirmed.
Qiu
Gui-xing
GX
Department of Orthopedics, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100730, China.
Li
Shu-gang
SG
Weng
Xi-sheng
XS
Tian
Ye
Y
Lin
Jin
J
Wang
Yi-peng
YP
Zhang
Jian-guo
JG
Jin
Jin
J
Zhao
Hong
H
Shen
Jian-xiong
JX
D000328:Adult; D000368:Aged; D001696:Biomechanical Phenomena; D004867:Equipment Design; D005260:Female; D006801:Humans; D016268:Internal Fixators; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D013168:Spondylolisthesis / Q000601:surgery*