UMIN-CTR Clinical Trial

Public title

Dynamic assessment of rotator cuff function by Cine-magnetic resonance imaging

Acronym

Dynamic assessment of rotator cuff function by Cine-MRI

Scientific Title

Dynamic assessment of rotator cuff function by Cine-magnetic resonance imaging

Scientific Title:Acronym

Dynamic assessment of rotator cuff function by Cine-MRI

Region

Japan

Condition

shoulder disorder

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Rotator cuff function is the most important feature to evaluate in a patient with a shoulder disorder. Rotator cuff muscles have been shown to be a stabilizer of the glenohumeral joint in multiple shoulder positions. However, assessment of rotator cuff function is still unknown. The purpose of this study was to accurately capture rotator cuff movements of healthy adults and patients with shoulder disorders by cine-magnetic resonance imaging (MRI) .

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

MRI scans of rotator cuff motion during internal and external shoulder rotation were obtained using Fast Imaging Employing Steady-state Acquisition (FIESTA) and Signa 1.5-tesla MRI device. During imaging, the hand was rotated from maximum pronation to maximum supination and the rotation was then reversed during 20 s. The same motion was assessed with the patient passive.An axial scout scan was taken in the center of humeral head for the assessment of glenohumeral joint congruity, internal and external rotation angles, and internal impingement during rotation.We examined the physical range of motion in flexion, abduction, external rotation and internal rotation at the side. Range of internal rotation was assessed by the score using constant score. All patients were evaluated by the Constant score and the shoulder rating scale of the University of California, Los Angels (UCLA) 39,40.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria of patients group were patients who felt pain in the shoulder region, who had no severe and global loss of passive motion (over 100 degree of forward flexion, over 10 degree of external rotation with the arm at the side, and internal rotation not more cephalad than the L5 level in passive range of motion).

Key exclusion criteria

patient who has severe limitation in the range of motion (ROM) of the shoulder, and history of injury around the shoulder, including the spine.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Tomonori Kemmoku

Organization

Kitasato university school of medicine

Division name

orthopaedic surgery

Zip code

Address

Kitazato 1-15-1 Minami-ku Sagamihara city, Kanagawa

TEL

042-778-8111

Email

pseudolefty811@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Tomonori Kemmoku

Organization

Kitasato university school of medicine

Division name

orthopaedic surgery

Zip code

Address

Kitazato 1-15-1 Minami-ku Sagamihara city, Kanagawa

TEL

042-778-8111

Homepage URL

Email

pseudolefty811@yahoo.co.jp

Institute

Department of Orthopaedic surgery, Kitasato university school of medicine

Institute

Department

Personal name

Organization

JSPS

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Cine-MRI produced scans of the rotator cuff coordinated movements with vivid clarity. All cases maintained congruity in normal group, however, seven shoulders were confirmed the loss of congruity in patients group. Patient group were significantly limitted in internal, external rotation, and total range of rotation.

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2016

Year

07

Month

05

Day

Date analysis concluded

2016

Year

07

Month

31

Day

Other related information

We divided patients into three groups by the limitation pattern of cine-MRI (the limitation of internal rotation, the limitation of iexternal rotation, and no limitation).Patients with the external rotational limitation were significantly lower than other patients in Constant score and UCLA score.

Registered date

2016

Year

08

Month

01

Day

Last modified on

2016

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026983