ENGLISH ABSTRACT
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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[Clinical application of unilateral pedicle screw for lumbar intervertebral disc protrusion].

OBJECTIVE: To explore the feasibility and effectiveness of unilateral pedicle screw rod and single poly (ether-ether-ketone) (PEEK) Cage for lumbar intervertebral disc protrusion.

METHODS: A total of 126 cases of single segment of lumbar intervertebral disc protrusion between January 2006 and June 2012 were divided into 2 groups in the randomized clinical trial. Unilateral pedicle screw fixation and single PEEK Cage was used in 63 cases (research group), and bilateral pedicle screw fixation and single PEEK Cage in 63 cases (control group). There was no significant difference in gender, age, disease duration, side, and affected segment between 2 groups (P > 0.05). Schulte evaluation criterion was used to assess bone graft fusion, Oswestry disability index (ODI) to estimate the quality of life situation, and visual analogue scale (VAS) to evaluate the improvements of lower back pain. Macnab standards was applied to assess postoperative effectiveness, and Emery ways to measure the height of intervertebral space.

RESULTS: The incision length, operation time, intraoperative blood loss, hospitalization time, and hospitalization fee in research group were significantly less than those in control group (P cc 0.05). The patients were followed up 12-79 months (mean, 21.3 months) in research group, and 15-73 months (mean, 22.6 months) in control group. The postoperative lordosis was recovered well, and the height of intervertebral space was increased. No loosening or breakage of internal fixation occurred. The time of bone graft fusion was (6.8 +/- 1.3) months in research group and was (7.1 +/- 1.2) months in control group, showing no significant difference (t = 1.153, P = 0.110). The height of intervertebral space, ODI score, and VAS score were significantly improved when compared with preoperative ones in 2 groups (P < 0.05), but no significant difference was found between 2 groups at preoperation and last follow-up (P > 0.05). At 3 months after operation, postoperative effectiveness was assessed according to Macnab criterion, the excellent and good rate was 95.23% in research group (excellent in 13 cases, good in 47 cases, and fair in 3 cases) and was 71.42% in control group (excellent in 7 cases, good in 38 cases, fair in 15 cases, and poor in 3 cases); the research group was significantly superior to control group (chi2 = 6.110, P = 0.006).

CONCLUSION: Unilateral pedicle screw fixation and single PEEK Cage has the advantages of small trauma, reliable fixation, shorter operation time, less bleeding, less economic cost, and early off-bed activity time. It can provide a simple and reliable choice in single segmental lumbar intervertebral disc protrusion.

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