Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas George H. Mohtadi

ORCID ID

Contact details

University of Calgary
Sport Medicine Centre
2500 University Drive NW
Calgary
T2N 1N4
Canada
+1 403-220-8563
mohtadi@ucalgary.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00251160

Protocol/serial number

MCT-64671

Study information

Scientific title

Acronym

Study hypothesis

This is a superiority trial with a hypothesis that there is an improvement in quality of life in patients undergoing ETAC compared with the open ICS.

Ethics approval

Faculty of Medicine, University of Calgary - 15th July 1999.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Shoulder instability

Intervention

1. Open ICS (open capsular shift)
2. ETAC (Arthroscopic electrothermal capsulorrhaphy)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Shoulder stability measured by the Western Ontario Shoulder Instability Index (WOSI)

Secondary outcome measures

1. Range of motion
2. Physical signs
3. Strength Instability

Overall trial start date

01/09/1999

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 14 years or greater, either sex
2. Diagnosis of Multidirectional Instability (MDI)
3. Informed written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58

Participant exclusion criteria

1. Neurologic disorder (e.g. axillary nerve injury; Syringomyelia)
2. Cases involving third party compensation
3. Patients with primary posterior instability

Recruitment start date

01/09/1999

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Canada

Trial participating centre

University of Calgary
Calgary
T2N 1N4
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

2500 University Drive N.W.
Calgary
T2N 1N4
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64671)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes