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
Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial.
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24939380 (added 31/01/2019)