UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000026072