A randomized prospective study of posterolateral lumbar fusion - Outcomes with and without pedicle screw instrumentation

Study Design. A prospective evaluation of the clinical and radiographic out comes of 71 patients who underwent lumbar fusion, with or without transpedi cular instrumentation. The patients completed a questionnaire that determin ed pain relief, medication use, return to work, and overall satisfaction wi th surgery. Objectives. To explore the effect, if any, of instrumentation on the outcom e of lumbar fusion surgery, according to reports of the patients, and wheth er there is a correlation between the radiographic determination of a solid fusion and the same patient-reported outcome. Summary of Background Data. The literature on this topic reports pseudarthr osis rates from 0% to 57% and good excellent results from 56% to 95%. These studies provide no clear-cut recommendations concerning the effect of adde d lumbar instrumentation on patient-reported outcome in a prospective manne r using concurrent control subjects. Methods. The patients were randomized to groups with and without instrument ation after deciding to undergo a lumbar fusion and consenting to enter the study. Radiographs were obtained and questionnaires filled out at 6 weeks, 6 months, 1 year, and 2 years after surgery. Results. There was no statistical difference in patient-reported outcome be tween the two groups. There was a slight nonsignificant trend toward increa sed radiographic fusion rate in the group with instrumentation that did not correlate with an increased patient-reported improvement rate. Conclusions. These results do not provide data that indicate a benefit in o utcome from added instrumentation in elective lumbar fusions.