10 years follow-up study of chemonucleolysis with condoliase

JRCT ID: jRCT1040220134

Registered date:02/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lumbar disc herniation
• Date of first enrollment: 01/03/2023
• Target sample size: 60
• Study type: Interventional
• 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 Outcome

1. 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 Outcome

1. Neurological examination: SLR test, hypoesthesia, muscle weakness, diminished deep tendon reflex
2. Dysfunction: ODI

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Ptients who had received condoliase 1.25 U injection in a phase III clinical study in Japan.

Exclude criteria

1. 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

• Primary Sponsor: Matsuyama Yukihiro