A new article published in Spine examines four randomized controlled clinical trials included in the Yale University Open Data Access Project on recombinant bone morphogenetic protein-2.
The researchers examined individual patient-level data for the four trials and examined the clinical outcomes between patients with raidographically confirmed fusion and those with radiographic non-union at one and two years after surgery.
There were 496 patients included in the study, with 5.5 percent who had radiographic non-unions which didn't require reoperation. The researchers found:
1. The patients with fusion reported better Oswestry Disability Index and Numeric Rating Scale back pain scores. The difference was significantly higher than nonunion patients.
2. The predictive value of fusion for the clinical outcomes was poor. There was low specificity and low negative predictive values.
3. The researchers concluded radiographic fusion was clinically significant because the patients reported better outcomes at one or two years after surgery.
4. The researchers also reported that patient-centered clinical outcomes should be taken into consideration as independent but complimentary when assessing the treatment's success.
5. A high resolution CT and radiolucent cages can show the most accurate fusion assessment.