A clinical study of ten-year prognosis in patients with lumbar disc herniation treated with condoliase in a phase III trial.

Abstract

Background: Condoliase is a chemonucleolytic agent approved in Japan for the treatment of lumbar disc herniation (LDH). There had been no follow-up evaluation of its long-term effects on discs covering a period exceeding 10 years.

Methods: The present study evaluated the 10-year post-dose outcomes of patients treated with condoliase during the phase III trial in terms of neurological results, Oswestry Disability Index (ODI), X-ray findings (disc height, posterior intervertebral angle, vertebral body translation), and magnetic resonance image findings (Modic classification, Pfirrmann grade).

Results: Among the 82 patients treated with condoliase during the phase III trial, 37 (45.1 %) were available for the 10-year post-dose follow-up in the present study. At 10 years post-dose, low back pain and leg pain were observed in 15 (40.5 %) and 6 (16.2 %) of 37 patients, and the number of patients with positive straight leg raise test, hypesthesia, muscle weakness, and deep tendon hyporeflexia were 1 (2.7 %), 2 (5.4 %), 0 (0 %), and 8 (21.6 %), respectively; mean ODI was 8.6, with 32/37 (86.5 %) patients having ODI of 0 %-20 %; 8 (21.6 %) patients had disc height decreased by ≥ 30 %; 1 patient had posterior intervertebral angle of ≥5° and 1 had vertebral body translation of ≥3 mm. Although 5 patients (13.5 %) underwent lumbar surgery after receiving condoliase, no patient underwent surgery for spinal instability. In the Modic classification, the number of patients with "Type 0," "Type 1," and "Type 3" decreased, while those with "Type 2" increased compared to evaluations conducted at 1-year post-dose. For Pfirrmann grade, the number of patients with "Grade IV" decreased and those with "Grade V″ increased from 1 to 10 years post-dose.

Conclusions: No significant imaging findings necessitating surgery were observed, suggesting that chemonucleolysis with condoliase remains a safe and effective treatment option for LDH over the long term.