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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022618
Receipt No. 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

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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
Email 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
Email titan@hama-med.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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