lumbar disc herniation
Conditions
Interventions
Participants will undergo the standard discectomy followed by Sodium Alginate solution injection. The Sodium Alginate solution (up to 2ml) will be placed into the intervertebral disc cavity using a s
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with lumbar disc herniation to plan discectomy (2) MRI evidence of intervertebral disc herniation corresponding to symptoms (3) Unresponsive to 6 consecutive weeks of therapy or experiencing acute/uncontrolled leg pain (80 mm or more out of 100 mm with VAS) (4) Candidate for a one-level lumbar discectomy procedure (5) Persistent and predominant leg pain (40 mm or more out of 100 mm with VAS) (6) Aged 20-50 (7) Informed consent is obtained after the sufficient explanation of this study
Exclusion criteria
Exclusion criteria: (1) Previous surgery involving index lumbar level (2) Prior or planned procedure to fuse the lumbar spine (3) The posterior bending angle of the intervertebral disc is recognized in any of the anterior bending, middle, and posterior bending of the lumbar spine X-ray image (4) Greater than grade I spondylolisthesis or retrolisthesis at affected level (5) Cauda equina syndrome (6) Acute local or systemic infection (7) Active malignancy or other similar comorbidities (8) Drug-dependent patients or alcohol dependence patients (9) Patients suffering from mental illness (10) Current fracture, tumour and/or deformity of the lumbar spine (11) Currently breast-feeding, pregnant, pregnancy during the trial period, or cannot do a highly effective contraceptive method (12) Other clinical trials within 4 weeks (13) Presence of any implanted metal or other contraindication to MRI (14) Diagnosed as positive for allergic reactions to sodium alginate by allergy test (prick test) (15) Contraindicated for this study due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Feasibility dMD-001 implantation The feasibility is evaluated as the implant achievement rate. With regard to implantation of dMD-001, judgment is made based on the criteria before or in surgery, and it is judged that implantation of dMD-001 is completed with the surface of dMD-001 being completely gelled. 2) Safety Adverse events occurred 24 weeks after implantation of dMD-001 are summarized as safety assessments. Safety is assessed with the incidence of adverse events that can not deny the relationship with dMD-001. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) VAS 2) FFD 3) SLR test 4) Modified Schober's test 5) JOA score 6) SF-36 7) ODI 8) RDQ 9) JOABPEQ 10) MRI signal change 11) Evaluation of dMD-001 implantation | — |
Countries
Japan
Contacts
Public ContactNozomi Yokota
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Outcome results
None listed