UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022376
Receipt number R000024987
Scientific Title In vivo elongation of cortical suspension device after double bundle ACL reconstruction -A three dimensional MRI and CT study
Date of disclosure of the study information 2016/05/20
Last modified on 2020/12/09 23:58:26

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Basic information

Public title

In vivo elongation of cortical suspension device after double bundle ACL reconstruction
-A three dimensional MRI and CT study

Acronym

In vivo elongation of cortical suspension device after double bundle ACLR

Scientific Title

In vivo elongation of cortical suspension device after double bundle ACL reconstruction
-A three dimensional MRI and CT study

Scientific Title:Acronym

In vivo elongation of cortical suspension device after double bundle ACLR

Region

Japan


Condition

Condition

Anterior cruciate ligament injury

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To address this, we propose a study where two types of cortical suspension devices are to be compared in terms of graft displacement after double bundle ACL reconstruction by examining graft position with the use of three dimensional MRI and CT analysis. Devices to be compared are Endbutton CL and Tightrope.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Subjects will receive three-dimentional, proton emphasis fat suppression MR images(132 slices) captured by 3.0T GE within a week after reconstruction, at 3, 6, and 12 months post op. CT data will be collect within a week after surgery and 12 months after surgery. Graft position is to be assessed using MRI data by imaging software where slices that run through the axis of femoral tunnel are reconstructed and distance between bottom of bone socket and the tip of graft are measured.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

end button CL

Interventions/Control_2

tight rope

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

15 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

The patient corresponding to all of the following conditions of interest

Grade2 or 3 in Lachman's test
Lateral pivot shift test is positive and, visualization of the ACL torn on MRI examination.

knee joint range of motion(flextion) is 120 degree or more
Patients enforce the range of motion training and muscle strength maintenance training preoperative.

the age less than 50 years from the epiphyseal line closed

Key exclusion criteria

The patients who falls under any of the following conditions are not included

Reinjury

Patients do not hope to sports activities and choose conservative treatment

Patients who wish to surgery with autologous tendon other than hamstring tendon

Patients with a medical disease that movement restriction has been instructed

Target sample size

30


Research contact person

Name of lead principal investigator

1st name takahisa
Middle name
Last name sasho

Organization

chiba university hospital

Division name

orthopedics

Zip code

260-8677

Address

1-8-1,inohana,chiba city chuoku,chiba

TEL

043-222-7171

Email

ys9964@gmail.com


Public contact

Name of contact person

1st name Yoshimasa
Middle name
Last name Ono

Organization

chiba university hospital

Division name

orthopedics

Zip code

260-8677

Address

1-8-1,inohana,chiba city chuoku,chiba

TEL

043-222-7171

Homepage URL


Email

y.ono@kbe.biglobe.ne.jp


Sponsor or person

Institute

chiba university hospital

Institute

Department

Personal name



Funding Source

Organization

arthrex japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

USA


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital Clinical Research Center

Address

1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN

Tel

043-226-2734

Email

chibacrc@mac.com


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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 20 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 05 Month 20 Day

Date of IRB

2016 Year 04 Month 13 Day

Anticipated trial start date

2016 Year 07 Month 20 Day

Last follow-up date

2018 Year 11 Month 19 Day

Date of closure to data entry

2019 Year 01 Month 28 Day

Date trial data considered complete

2019 Year 04 Month 17 Day

Date analysis concluded

2019 Year 06 Month 05 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 20 Day

Last modified on

2020 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name