Combined lumbar canal stenosis
Conditions
Interventions
None listed
Sponsors
Hideki Sudo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Willingness to provide written informed consent, fill in all necessary questionnaires, and return for follow-up.
Exclusion criteria
Exclusion criteria: Any other reason judged by an investigator or clinical trial doctor that renders the candidate unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Safety Adverse events occurring from 48 weeks to 96 weeks after the surgical treatment will be summarized with laboratory tests used as a safety assessment. The incidence of adverse events undeniably related to the investigational product in the physician-initiated clinical trial will be evaluated in the REC-02-dMD-001 implantation group, the dMD-001 implantation group, and the herniaectomy group. 2)Effectiveness The respective pain scores (VAS) for low back pain and leg pain (for both the most painful leg and the contralateral leg) [5] and MRI imaging assessment (modified Pfirrmann classification, disc height index (DHI), T1 mapping, T2* mapping, DWI) will be conducted. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) JOA score 2) SF-36 3) ODI 4) RDQ 5) JOABPEQ 6) Zurich Lameness Questionnaire | — |
Contacts
Public ContactSudo Hideki
Hokkaido University Hospital
Outcome results
None listed