UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022618 |
|---|---|
| Receipt number | R000026072 |
| Scientific Title | Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage for posterior lumbar interbody fusion, a multicenter, randomized, open-label, parallel-group trial |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2019/05/06 05:53:52 |
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Basic information
Public title
Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage for posterior lumbar interbody fusion, a multicenter, randomized, open-label, parallel-group trial
Acronym
Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage
Scientific Title
Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage for posterior lumbar interbody fusion, a multicenter, randomized, open-label, parallel-group trial
Scientific Title:Acronym
Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage
Region
| Japan |
Condition
Condition
Lumbar canal stenosis, lumbar disc herniation, lumbar radiculopathy, spondylosis, spondylolisthesis, lumbar kyphoscoliosis, lumbar scoliosis, and lumbar kyphosis which need posterior interbody fusion
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the difference of
-bony fusion rate and period
-rate of pseudoarthrodesis
-loosening of pedicle screws
-clinical symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
By X-ray or CT image at 2M,4M,6M,9M and 12M after surgery
1.Fusion rate
2.Rate of intervertebral disc narrowing and instability
3.Occurrence rate of screw loosening
Key secondary outcomes
Improvement of ADL and QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We perform posterior lumbar interbody fusion with PEEK interbody cage.
Interventions/Control_2
We perform posterior lumbar interbody fusion with titanium coated PEEK interbody cage.
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
1. Patients who are eligilble for one level spinal fusion surgery for having lumbar degenerative disease (Lumbar canal stenosis, lumbar disc herniation, lumbar radiculopathy, spondylosis, spondylolisthesis, lumbar kyphoscoliosis, lumbar scoliosis, and lumbar kyphosis)
2. Patients 20 years of age or older at the time of signing consent form
Key exclusion criteria
1.Patients 19 years of age or younger at the time of signing consent form
2.Patients whom the attending physician investigator has determined to be unsuitable for the conduct of the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Matsuyama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
431-3192
Address
1-20-1Handayama Hamamatsu Higashi-ku, Shizuoka Japan431-3192
TEL
053-435-2299
titan@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Hasegawa |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
431-3192
Address
1-20-1 Handayama Hamamatsu Higashi-ku, Shizuoka Japan431-3192
TEL
053-435-2299
Homepage URL
titan@hama-med.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
B.Braun Aesculap Japan Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujiyoshida Municipal Hospital
Enshu Hospita
Hamamatsu Sekijuji Hospital
Iwata City Hospital
Jyuzen Memorial Hospital
Hamamatsu Medical Center
Narita Memorial Hospital
Fujieda municipal General Hospital
Fujinomiya City General Hospital
Kikugawa General Hospital
Shizuoka municipal Hospital
Shinonoi General Hospital
North Alps Medical center Azumi Hospital
Ina Central Hospital
Suwa sekijuji Hospital
Yamanashi Prefectural Central Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
institutional review boards of Hamamatsu University School of Medicine
Address
1-20-1 Handayama Hamamatsu Higashi-ku, ShizuokajJapan,431-3192
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学附属病院（静岡県）、遠州総合病院 （静岡県）、浜松赤十字病院（静岡県）、磐田市立総合病院 （静岡県）、十全記念病院 （静岡県）、浜松医療センター （静岡県）、成田記念病院 （愛知県）、藤枝市立総合病院（静岡県）、
富士宮市立病院（静岡県）、菊川市立総合病院（静岡県）、静岡市立静岡病院（静岡県）、山梨大学附属病院（山梨県）、 富士吉田市立病院（山梨県）、山梨県立中央病院（山梨県）、信州大学附属病院（長野県）、伊那中央病院 （長野県）、
諏訪赤十字病院（長野県）、篠ノ井総合病院 （長野県）、 あづみ病院 （長野県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026072
