UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023429 |
|---|---|
| Receipt number | R000026999 |
| Scientific Title | A prospective study of anterior decompression with fusion and posterior decompression with laminoplasty for the treatment of cervical spondylotic myelopathy |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2016/08/01 18:51:16 |
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Basic information
Public title
A prospective study of anterior decompression with fusion and posterior decompression with laminoplasty for the treatment of cervical spondylotic myelopathy
Acronym
A prospective comparative study for CSM
Scientific Title
A prospective study of anterior decompression with fusion and posterior decompression with laminoplasty for the treatment of cervical spondylotic myelopathy
Scientific Title:Acronym
A prospective comparative study for CSM
Region
| Japan |
Condition
Condition
Cervical spondylotic myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anterior decompression with fusion (ADF) and posterior decompression with laminoplasty (LAMP) are both effective surgical procedures for cervical spondylotic myelopathy (CSM). Previously we reported that ADF provided superior neurologic outcomes to LAMP at 5 years after operation. In this study, we update the data to assess long-term clinical and radiologic outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical outcomes were evaluated by comparing the recovery rate of the Japanese Orthopaedic Association (JOA) score between the two groups. Radiographs were taken before surgery and every year after surgery. Sagittal alignment of the C2-7 lordotic angle and range of motion (ROM) in flexion and extension were measured before and after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Anterior decompression with fusion
Interventions/Control_2
Posterior decompression with laminoplasty
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cervical spondylotic myelopathy
Key exclusion criteria
Patients with myelopathy caused by cervical disc herniation and ossification of the posterior longitudinal ligament (OPLL), those with radiculopathy, and those with a history of previous cervical spine surgery or injury
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Hirai |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
hirai.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Hirai |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
Homepage URL
hirai.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/21289554
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 1996 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1996 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2016 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026999
