Unique ID issued by UMIN | UMIN000035455 |
---|---|
Receipt number | R000040394 |
Scientific Title | Randomized non-inferiority test of reduced implant laminoplasty. |
Date of disclosure of the study information | 2019/02/01 |
Last modified on | 2022/01/12 11:29:43 |
Randomized non-inferiority test of reduced implant laminoplasty.
SKIP-2
Randomized non-inferiority test of reduced implant laminoplasty.
SKIP-2
Japan |
cervical spodylotic myelopathy
Orthopedics |
Others
NO
To evaluate the non-inferiority of implant reduced laminoplasty compare to the standard one.
Bio-equivalence
cervical JOA score 2 years postoperatively
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Maneuver |
Tha group undergo the laminoplasty with four implants
Tha group undergo the laminoplasty with teo implants
60 | years-old | <= |
100 | years-old | >= |
Male and Female
1. Patients who will undergo lamioplasty for cervical spondylotic myelopathy in the Osaka City Unviversity Hospital or related instituion
2. Patients who will undergo lamioplasty from C3-C6
3. Patients who is equal or more than 60 years old
4. Patients with agreement after provided informed consent
1. Patients with severe cervical kyphosis
2. Patients with severe cervical instabilitiy
3. Patients with history of previous cervical surgery
4. Patient with severe OPLL
5. Patient with severe renal disease
6. Patient with severe liver disease
160
1st name | Akinobu |
Middle name | |
Last name | Suzuki |
Osaka City University
Orthopedics
545-8585
Asahimachi
0666453851
koji.tamai@msic.med.osaka-cu.ac.jp
1st name | Koji |
Middle name | |
Last name | Tamai |
Osaka City University
Orthopedics
545-8585
Asahimachi
0666453851
koji.tamai@msic.med.osaka-cu.ac.jp
Osaka City University
Self funding
Self funding
IRB of Osaka City Univeristy
Asahimachi
+81666453851
ethics@med.osaka-cu.ac.jp
YES
4170
Osaka City University Hospital Certified Review Board
2019 | Year | 02 | Month | 01 | Day |
Unpublished
No longer recruiting
2018 | Year | 11 | Month | 22 | Day |
2018 | Year | 11 | Month | 22 | Day |
2019 | Year | 02 | Month | 01 | Day |
2024 | Year | 02 | Month | 28 | Day |
2019 | Year | 01 | Month | 05 | Day |
2022 | Year | 01 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040394
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