The researchers examined patient data from four randomized controlled trials from the Yale University Open Data Access Project. There were 496 patients included in the study that had one and two-year follow-up data. The researchers found:
1. There were 5.5 percent of the patients with radiographic nonunions that didn’t require reoperation.
2. The patients who showed fusion reported better Oswestry Disability Index scores and Numeric Rating Scale back pain scores.
3. The percentage of patients who reported fusion that exceeded the minimal clinically important criteria for ODI and NRS back pain scores was significantly higher than among the patients who reported nonunions.
4. The predictive values of fusion for clinical outcomes were poor, with low specificity and low negative predictive values.
5. The researchers concluded radiographic fusion is clinically significant because patients with fusion reported better one- and two-year clinical outcomes.
“However, patient-centered clinical outcomes should also be taken into consideration as independent, complimentary variables when assessing treatment success,” concluded the study authors.
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