Efficacy and Safety of Condoliase Disc Administration as a New Treatment for Lumbar Disc Herniation

  • Inoue Masahiro
    Department of Orthopaedic Surgery, Eastern Chiba Medical Center
  • Sainoh Takeshi
    Department of Orthopaedic Surgery, Sainou Hospital
  • Kojima Atsushi
    Department of Orthopaedic Surgery, Funabashi Orthopaedic Hospital
  • Yamagata Masatsune
    Department of Orthopaedic Surgery, Chiba Rosai Hospital
  • Morinaga Tatsuo
    Department of Orthopaedic Surgery, Kashiwa Municipal Hospital
  • Mannoji Chikato
    Department of Orthopaedic Surgery, Japanese Red Cross Narita Hospital
  • Ataka Hiromi
    Department of Orthopaedic Surgery, Matsudo Orthopaedic Hospital
  • Yamashita Masaomi
    Department of Orthopaedic Surgery, Funabashi Central Hospital
  • Takahashi Hiroshi
    Department of Orthopaedic Surgery, University of Tsukuba
  • Saito Junya
    Department of Orthopaedic Surgery, Toho University of Sakura Hospital
  • Fujiyoshi Takayuki
    Department of Orthopaedic Surgery, Kimitsu Chou Hospital
  • Ishikawa Tetsuhiro
    Department of Orthopaedic Surgery, Sanmu Medical Center
  • Eguchi Yawara
    Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
  • Kato Kei
    Department of Orthopaedic Surgery, Matsudo City General Hospital
  • Orita Sumihisa
    Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
  • Inage Kazuhide
    Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
  • Shiga Yasuhiro
    Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
  • Norimoto Masaki
    Department of Orthopaedic Surgery, Toho University of Sakura Hospital
  • Umimura Tomotaka
    Department of Orthopaedic Surgery, Sanmu Medical Center
  • Shiko Yuki
    Biostatistics Section, Clinical Research Center, Chiba University Hospital
  • Kawasaki Yohei
    Biostatistics Section, Clinical Research Center, Chiba University Hospital
  • Aoki Yasuchika
    Department of Orthopaedic Surgery, Eastern Chiba Medical Center
  • Ohtori Seiji
    Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University

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<p>Introduction: Condoliase is a newly approved drug that improves symptoms associated with lumbar disk herniation (LDH) by intradiscal administration. This study aimed to evaluate the mid-term outcomes of condoliase injection, examine the adverse events, including cases that required surgery after condoliase administration, and verify cases in which condoliase could be effective.</p><p>Methods: We enrolled patients with LDH who were treated conservatively for at least six weeks and received condoliase. We assessed the visual analog scale (VAS) score, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, Oswestry Disability Index, disk height, and disk degeneration for up to 6 months, and we examined the complications. Furthermore, a 50% or more improvement in leg pain VAS score was considered effective. Factors related to symptom improvement were investigated by determining whether lower limb pain improved in six months.</p><p>Results: In total, 84 patients were recruited (52 men, 32 women; mean age, 44.2 ± 17.1 [16-86 years]). The duration of illness was 6.7 ± 6.8 (1.5-30) months. All patient-based outcomes significantly improved at 4 weeks after the administration compared with pretreatment. The intervertebral disc height decreased significantly at four weeks after condoliase administration compared with that before administration. Progression of intervertebral disc degeneration occurred in 50% of the patients. Eleven patients underwent herniotomy due to poor treatment effects. Moreover, treatment in 77.4% of the patients was considered effective. A logistic regression analysis revealed that L5/S1 disk administration (p = 0.029; odds ratio, 5.94; 95% confidence interval, 1.20-29.45) were significantly associated with clinical effectiveness.</p><p>Conclusions: Condoliase disk administration improved pain and quality of life over time. Condoliase disk administration was more effective in L5/S1 intervertebral administration.</p>

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