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

10 years follow-up study of chemonucleolysis with condoliase

37

The mean age of subjects who agreed to participate in this study (administered 1.25 U of condoliase during the Japanese Phase III trial) was 50.9 years (31-74 years) at the time of the study. The mean time from the date of condoliase administration until the date of consent to the study was approximately 10.6 years, and it was more than 10 years for all subjects. The gender ratio was 56.8% male (21/37) and 43.2% female (16/37). The site of condoliase administration was L4/L5 in 59.5% (22/37), L5/S1 in 40.5% (15/37), and L5/L6 in 0.0% (0/37).

Of 82 subjects, 37 agreed to participate in this study, all of whom were deemed suitable in the eligibility assessment, meeting all inclusion criteria without violating any exclusion criteria, and all of them completed the study.

No adverse events occurred during the study period.

Primary Endpoint 1. Intervertebral disc height The percent change from the baseline for intervertebral disc height (mean plus or minus standard deviation) was -11.9 plus or minus 10.8% at the end of the clinical trial and -20.3 plus or minus 14.5% at the time of the study evaluation. At this evaluation, 21.6% (8/37) of the subjects had a 30% or greater decrease in disc height from baseline. Changes after the end of the clinical trial showed an increase in disc height in 12 of the 37 subjects, and of those who showed a decrease, the rate of change from the end of the clinical trial was reduced by 30% or more in 4 subjects. 2. Posterior opening angle The proportion of subjects with a vertebral posterior opening angle of 5 degrees or more was 10.8% (4/37) at the end of the clinical trial and 2.7% (1/37) at the time of this study evaluation. 3. Vertebral body slippage The proportion of subjects with vertebral slippage of 3 mm or more was 2.7% (1/37) at the end of the clinical trial and 2.7% (1/37) at the time of study evaluation. 4. Modic classification At the end of the clinical trial and at the time of this study evaluation, the numbers of subjects who were Type 0, Type 1, Type 2, and Type 3 were 20, 8, 8, and 1 at the end of the clinical trial and 13, 3, 21, and 0 at the time of this study evaluation, respectively. Of the eight subjects who were Type 1 at the end of the clinical trial, seven had changed to Type 2 at the time of this study evaluation, and of the eight subjects who were Type 2 at the end of the clinical trial, seven remained Type 2 at the time of this study evaluation. 5. Pfirrmann classification There were no Grade I or Grade II subjects at the end of the clinical trial or at the time of this study evaluation. The numbers of subjects who were Grade III, Grade IV, and Grade V were 4, 32, and 1 at the end of the clinical trial, and 3, 24, and 10 at the time of evaluation in this study, respectively. At the time of this study evaluation, Grade IV subjects decreased and Grade V subjects increased compared to the end of the clinical trial. Secondary Endpoints 1. Neurological examination At the time of this study evaluation, the proportion of subjects whose SLR test was positive in 2.7% (1/37), hypoesthesia was present in 5.4% (2/37), muscular weakness was present in 0% (0/37), and diminished deep tendon reflex was present in 21.6% (8/37). 2. Oswestry Disability Index (ODI) The mean plus or minus standard deviation of ODI was 8.6 plus or minus 11.7, and the totals by classification were 86.5% (32/37) at 0-20% (minimal disability), 10.8% (4/37) at 21-40% (moderate disability), 2.7% (1/37) at 41-60% (severe disability), and 0% (0/37) at 61-80% or above (crippled).

There were no patients who underwent lumbar surgery due to spinal instability during 10 years after condoliase treatment. Moreover, no adverse events occurred during the study period. A 10-year long-term prognosis survey of subjects who had been administered condoliase in a Japanese Phase III trial revealed no long-term effects of condoliase on the intervertebral disc.

Mar. 31, 2025

Mar. 31, 2025

https://jssr2025.org/

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1040220134

Matsuyama Yukihiro

Hamamatsu University School of Medicine

1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan.

spine-yu@hama-med.ac.jp

Matsuyama Yukihiro

Hamamatsu University School of Medicine

1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan.

+81-53-435-2297

spine-yu@hama-med.ac.jp

Complete

Dec. 27, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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

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.

Both

Lumbar disc herniation

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.

Lumbar disc herniation

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)

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

+81-53-435-2680

Dec. 27, 2022

+81-52-201-5311

Dec. 27, 2022

+81-3-5693-8341

Dec. 27, 2022

none