UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032338 |
|---|---|
| Receipt number | R000036873 |
| Scientific Title | Recovery Process in Patients with Cervical Laminoplasty |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/04/21 01:19:30 |
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Basic information
Public title
Recovery Process in Patients with Cervical Laminoplasty
Acronym
Recovery Process Using JOACMEQ
Scientific Title
Recovery Process in Patients with Cervical Laminoplasty
Scientific Title:Acronym
Recovery Process Using JOACMEQ
Region
| Japan |
Condition
Condition
Cervical spondylotic myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypothesis is made that the tendency of recovery process using the conventional JOA score and JOACMEQ, a patient-based evaluation, are different. Our object is to investigate the functional recovery process with laminoplasty performed to CSM using JOACMEQ.
Basic objectives2
Others
Basic objectives -Others
Our object is to clarify the relationship between the image evaluation using Xp, MRI, etc. and the improvement of the function after the operation.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
For the same patient, JOACMEQ are scored at each time point before operation, 1 month, 3 months, 6 months, 1 year and 2 years after operation. And we consider trends of recovery for each domain.
Key secondary outcomes
From image evaluation before and after operation, factors influencing postoperative results will be examined.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of performed cervical laminoplasty for cervical spondylosis myelopathy
Key exclusion criteria
1. Under 19 years old cases
2. Cases in which the postoperative evaluations are missed at least one point during 2 years after the operation
3. Infection
4. Dialysis cases
5. Trauma cases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Shigematsu |
Organization
Nara medical university
Division name
Orthopedic Surgery
Zip code
Address
840 Shijyo-cho, Kashihara shi, Nara Prefecture
TEL
0744-22-3051
shideki@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Shigematsu |
Organization
Nara medical university
Division name
Orthopedic Surgery
Zip code
Address
840 Shijyo-cho, Kashihara shi, Nara Prefecture
TEL
0744-22-3051
Homepage URL
shideki@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university
Orthopedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Nara medical university
Orthopedic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
奈良県立医科大学（奈良県）、香芝旭ヶ丘病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study to evaluate postoperative recovery process
Management information
Registered date
| 2018 | Year | 04 | Month | 21 | Day |
Last modified on
| 2018 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036873
