UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017435
Receipt number R000020214
Scientific Title Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?
Date of disclosure of the study information 2015/05/07
Last modified on 2015/05/06 20:12:40

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Basic information

Public title

Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?

Acronym

Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?

Scientific Title

Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?

Scientific Title:Acronym

Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?

Region

Japan


Condition

Condition

Initial shoulder dislocation

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to determine the efficacy of this motion restriction band in reducing the recurrence rate after immobilization in external rotation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome measure was the recurrence of dislocations of the shoulder.

Key secondary outcomes

(1) when and how the recurrent dislocation had occurred
(2) whether they had returned to their preinjury sports.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

After 3 weeks of immobilization in external rotation, a shoulder motion restriction band designed to avoid stretching the anteroinferior shoulder capsule was used for 0 weeks.

Interventions/Control_2

After 3 weeks of immobilization in external rotation, a shoulder motion restriction band designed to avoid stretching the anteroinferior shoulder capsule was used for 3 weeks.

Interventions/Control_3

After 3 weeks of immobilization in external rotation, a shoulder motion restriction band designed to avoid stretching the anteroinferior shoulder capsule was used for 6 weeks.

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


 Not applicable

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

The inclusion criteria were those (1) with an initial anterior dislocation of the shoulder with a significant traumatic event that required manual reduction by a third party, (2) seen within 3 days of dislocation, and (3) who had no associated fractures of the shoulder detectable on routine radiographic examination.

Key exclusion criteria

The exclusion criteria were those (1) with associated fractures of the affected shoulder, (2) with injuries to any other part of the body, and (3) with a previous operative treatment of the affected shoulder.

Target sample size

109


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Itoi

Organization

Tohoku University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan

TEL

022-717-7245

Email

itoi-eiji@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Itoi

Organization

Tohoku University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

Seiryo-machi 1-1, Aoba-ku, Sendai 980-8574, Japan

TEL

022-717-7245

Homepage URL


Email

itoi-eiji@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tohoku University School of Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Akita University School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 05 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Of 109 patients, 90 were followed up for 2 years. The compliance rates were 60% to 72% among the groups (P = .54). The recurrence rate of dislocation was 28% in the 0-week group, 33% in the 3-week group, and 32% in the 6-week group (P = .88) according to the intention-to-treat analysis, and they were a respective 24%, 28%, and 27% according to the per-protocol analysis (P = .95). Based on the sport activity level, the recurrence rates for patients involved in contact sports (7/15, 47%) and those involved in noncontact sports (19/51, 37%) were significantly higher than for those not involved in sport activities (2/24, 8.3%) (P = .0076). Among the 3 groups, there were no significant differences in the recurrence rates. There was no significant difference in the rate of return to sports (P = .39).

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

2004 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2011 Year 08 Month 31 Day

Date of closure to data entry

2011 Year 12 Month 31 Day

Date trial data considered complete

2011 Year 12 Month 31 Day

Date analysis concluded

2012 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 05 Month 06 Day

Last modified on

2015 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=R000020214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name