NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1040220134

Registered date:02/02/2023

10 years follow-up study of chemonucleolysis with condoliase

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedLumbar disc herniation
Date of first enrollment01/03/2023
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Subjects who are not currently attending the hospital will be asked to visit the hospital at least once for examination. There is no research period for each subject.

Outcome(s)

Primary Outcome1. Disc height 2. Posterior intervertebral angle 3. Vertebral body translation 4. Changes in cartilage endplates and adjacent vertebral bodies (change in Modic Type) 5. Intervertebral disc degeneration (Pfirrmann classification)
Secondary Outcome1. Neurological examination: SLR test, hypoesthesia, muscle weakness, diminished deep tendon reflex 2. Dysfunction: ODI

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteriaPtients who had received condoliase 1.25 U injection in a phase III clinical study in Japan.
Exclude criteria1. Ptients for whom consent do not been obtained in this study. 2. Ptients who are judged unsuitable for conducting this study by the principal investigator, and some others.

Related Information

Contact

Public contact
Name Yukihiro Matsuyama
Address 1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan. Shizuoka Japan 431-3192
Telephone +81-53-435-2297
E-mail spine-yu@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine
Scientific contact
Name Yukihiro Matsuyama
Address 1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan. Shizuoka Japan 431-3192
Telephone +81-53-435-2297
E-mail spine-yu@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine