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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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