Predictive Factors for Poor Outcome following Chemonucleolysis with Condoliase in Lumbar Disc Herniation

Abstract

Background and Objectives: Condoliase, a chondroitin sulfate ABC endolyase, is a novel and minimally invasive chemonucleolytic drug for lumbar disc herniation. Despite the growing number of treatments for lumbar disc herniation, the predicting factors for poor outcomes following treatment remain unclear. The aim of this study was to determine the predictive factors for unsuccessful clinical outcome following condoliase therapy. Material and Methods: We performed a retrospective single-center analysis of 101 patients who underwent chemonucleolysis with condoliase from January 2019 to December 2021. Patients were divided into good outcome (i.e., favorable outcome) and poor outcome (i.e., requiring additional surgical treatment) groups. Patient demographics and imaging findings were collected. Clinical outcomes were evaluated using the numerical rating scale and Japanese Orthopaedic Association scores at baseline and at 1- and 3-month follow-up. Pretreatment indicators for additional surgery were compared between the 2 groups. Results: There was a significant difference in baseline leg numbness between the good outcome and poor outcome groups (6.27 ± 1.90 vs. 4.42 ± 2.90, respectively; p = 0.033). Of the 101 included patients, 32 received a preoperative computed tomography scan. In those patients, the presence of calcification or ossification in disc hernia occurred more often in the poor outcome group (61.5% vs. 5.3%, respectively; p < 0.001; odds ratio = 22.242; p = 0.014). Receiver-operating characteristics curve analysis for accompanying calcification or ossification showed an area under the curve of 0.858 (95% confidence interval, 0.715−1.000; p = 0.001). Conclusions: Calcified or ossified disc herniation may be useful predictors of unsuccessful treatment in patients with condoliase administration.

Keywords: calcification; chemonucleolysis; chondroitin sulfate ABC endolyase; condoliase; lumbar disc herniation; ossification.

Figure 1

Patient selection flow.

Figure 2

Changes in the numerical rating scale (NRS) of back pain, leg pain, and leg numbness, and the Japanese Orthopaedic Association (JOA) scores after chemonucleolysis with condoliase.

Figure 3

Illustrative example of a patient in the poor group with a calcified disc herniation. T2-weighted sagittal (A) and axial (B) magnetic resonance images show an L5/S1 disc herniation. Sagittal (C) and axial (D) computed tomography myelography helped to confirm the calcified disc herniation.

Figure 4

Receiver-operating characteristics (ROC) curve analysis of the logistic regression model provided an area under the curve of 0.858 (95% confidence interval, 0.715–1.000).