Lumbar Disc Herniation Lumbar Disc Herniation
Conditions
Interventions
A lumbar disc herniation excision procedure is performed. In the dMD-001 implantation group, dMD-001 is implanted into the defect site. After administration (filling), a calcium chloride solution is a
D017586
Sponsors
Yamada Katsuhisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with lumbar disc herniation scheduled for discectomy (2) Patients with MRI-confirmed disc herniation at a site consistent with neurological symptoms (3) Patients with lower limb pain unimproved after 6 weeks of conservative treatment, or patients with acute onset of intolerable lower limb pain (80 mm or more within 100 mm on the VAS) (4) Patients with a lumbar disc herniation at a single intervertebral level (5) Patients with an Oswestry Disability Index (ODI) score of 50 or higher on the pre-enrollment assessment conducted after obtaining informed consent (6) Patients aged 18 years or older at the time of obtaining informed consent (7) Patients who have received a thorough explanation of the trial details, fully understand them, and have provided written informed consent
Exclusion criteria
Exclusion criteria: (1) Patients with a history of surgery at the planned site for lumbar disc herniation excision (2) Patients with a history of spinal fusion surgery or those scheduled for such surgery (3) Patients showing posterior disc space widening in the flexion, neutral, or extension position on plain lumbar radiographs (4) Patients with Grade I or greater spondylolisthesis at the affected level (5) Patients whose average disc height (calculated by averaging the anterior and posterior heights of the target disc in the neutral lumbar plain radiograph) is less than half the average height of the adjacent non-degenerative (Pfirrmann grade 2 or lower*1) disc. However, for L5/S disc herniation, if the adjacent disc (L4/5) is degenerated with reduced disc height, the L3/4 disc shall be used as the reference. (6) Patients suffering from acute localized or systemic infections (7) Patients suffering from malignant diseases (8) Patients with drug dependence or alcohol dependence (9) Patients suffering from psychiatric disorders (10) Patients with lumbar fractures, tumors, or deformities visible on X-ray images (11) Patients who are currently breastfeeding, pregnant, or wish to become pregnant during the trial period; patients whose partner wishes to become pregnant; or patients unable to use highly effective contraception*2 (12) Patients who participated in another trial within 4 weeks prior to consent acquisition that may be judged to affect this trial (13) Patients unable to undergo MRI examination due to implanted metal devices (e.g., pacemakers) or conditions such as claustrophobia (14) Patients with a history of treatment with chondriase or currently undergoing such treatment (15) Patients with combined canal stenosis (16) Patients with a history of hypersensitivity to substances derived from seaweed (17) Other patients deemed unsuitable for this trial by the principal investigator or sub-investigator *1 Evaluated by the principal investigator or sub-investigator at the clinical trial site *2 Examples of contraceptive methods: Condoms, diaphragms, oral contraceptives, intrauterine devices (IUDs), etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Symptoms and Structural Improvement (1) Change in ODI at 96 weeks post-surgery compared to the pre-observation period (2) Percentage of patients with a reduction of one or more levels in disc degeneration assessment (Pfirrmann classification) at 96 weeks post-surgery compared to the pre-observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in ODI at 1, 4, 12, and 48 weeks post-surgery compared to the pre-observation period 2) Change in lower limb pain VAS at 1, 4, 12, 48, and 96 weeks post-surgery compared to the pre-observation period 3) Change in DHI at 48 and 96 weeks post-surgery compared to the pre-observation period 4) Texture contrast values at 48 and 96 weeks post-surgery compared to the pre-observation period 5) Safety Adverse events occurring from the time of nucleus pulposus excision through 96 weeks post-surgery, and serious malfunctions occurring during the storage period of the investigational device from delivery through retrieval and disposal will be summarized as part of the safety evaluation. For adverse events, the incidence rate will be evaluated in each group. For serious malfunctions, the incidence rate will be evaluated. | — |
Contacts
Public ContactNozomi Yokota
Hokkaido University Hospital
Outcome results
None listed