UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042282 |
|---|---|
| Receipt number | R000048247 |
| Scientific Title | A study on clinical outcomes of lumbar disc herniation surgery and evaluation of disc degeneration by MRI |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/12/04 13:33:30 |
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Basic information
Public title
A study on clinical outcomes of lumbar disc herniation surgery and evaluation of disc degeneration by MRI
Acronym
A study on clinical outcomes of lumbar disc herniation surgery and evaluation of disc degeneration by MRI
Scientific Title
A study on clinical outcomes of lumbar disc herniation surgery and evaluation of disc degeneration by MRI
Scientific Title:Acronym
A study on clinical outcomes of lumbar disc herniation surgery and evaluation of disc degeneration by MRI
Region
| Japan |
Condition
Condition
lumbar disc herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate surgical outcomes in patients with lumbar disc herniation after lumbar discectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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 surgery
12) Safety
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key 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
Key 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) Contraindicated for this study due to other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Sudo |
Organization
Hokkaido University Hospital
Division name
Department of Orthopedic surgery
Zip code
060-8638
Address
North-15, West-7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5936
hidekisudo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical Innovation Center
Zip code
060-8638
Address
North-14, West-5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7735
Homepage URL
nozomi.yokota@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Developmen
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Mochida Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Hokkaido University Hospital Division of Clinical Research Administration
Address
North-14, West-5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）、えにわ病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
Results
Results date posted
| 2023 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048247
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