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The Comparison of Pedicle Screw and Cortical Screw in Posterior Lumbar Inter-body Fusion: a Prospective Randomized Non-inferiority Trial.

The Comparison of Pedicle Screw and Cortical Screw in Posterior Lumbar Inter-body Fusion: a Prospective Randomized Non-inferiority Trial.

Spine J. 2015 Feb 26;

Authors: Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS

BACKGROUND CONTEXT: Pedicle screws (PS) offer great benefits in posterior lumbar inter-body fusion (PLIF), but several drawbacks of PS, including the risk of superior facet joint violation and muscle injury, have also pointed out. Recently, cortical screws (CS) were invented, which can be placed without the drawbacks associated with PS. However, whether or not CS in PLIF can provide similar or greater clinical and radiological outcomes compared to those of PS has not been fully evaluated in clinical research studies.
PURPOSE: To evaluate whether the CS provides similar results to the PS in PLIF, in terms of fusion rate, clinical and surgical outcomes, and complications.
STUDY DESIGN: Prospective, randomized, non-inferiority trial PATIENT SAMPLE: Seventy-nine eligible patients were randomly assigned to either group A (39 patients), for which PS was utilized, or group B (40 patients), for which CS was utilized.
OUTCOME MEASURE: The primary study endpoint was to measure fusion rate using dynamic radiographs and CT scans. Secondary endpoints included intensity of lower back pain and pain radiating to the leg using visual analogue scales, and also, functional status using the Oswestry disability index, surgical morbidity, and additional outcomes such as pedicle fracture and mechanical failure.
METHODS: We compared baseline data in both groups. To evaluate the efficacy of CS in PLIF compared to PS, we compared fusion rates, clinical outcomes, and complications after surgery in both groups. No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
RESULTS: At the six- and twelve-month follow-up points, similar fusion rates were observed in both groups (P = 0.81 and 0.61, respectively). According to the clinical outcome, CS provided similar improvements in pain amelioration and functional status compared to PS, with no significant differences. Additionally, CS resulted in significantly less surgical morbidity, including shorter incision length, quicker operative time, and less blood loss, compared to PS.
CONCLUSION: CS in PLIF provides similar clinical and radiological outcomes compared to PS in PLIF. Based on the current study, we suggest CS to be a reasonable alternative to PS in PLIF.

PMID: 25728553 [PubMed – as supplied by publisher]

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