10 years follow-up study of chemonucleolysis with condoliase

10 years follow-up study of chemonucleolysis with condoliase after phase III clinical trials (6603/1031) of condoliase for lumbar disc herniation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1040220134

Enrollment

Registered

2023-02-02

Start date

2023-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar disc herniation Lumbar disc herniation

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ptients who had received condoliase 1.25 U injection in a phase III clinical study in Japan.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

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

Contacts

Public ContactYukihiro Matsuyama

Hamamatsu University School of Medicine

spine-yu@hama-med.ac.jp+81-53-435-2297

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026