[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.

CONCLUSION

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.