Arthroscopic electrothermal capsulorrhaphy, ETAC, versus open capsular shift, ICS, for patients with shoulder instability: A multicentre randomized clinical trial

ISRCTN ISRCTN68224911
DOI https://doi.org/10.1186/ISRCTN68224911
ClinicalTrials.gov number NCT00251160
Secondary identifying numbers MCT-64671
Submission date
09/09/2005
Registration date
09/09/2005
Last edited
31/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nicholas George H. Mohtadi
Scientific

University of Calgary
Sport Medicine Centre
2500 University Drive NW
Calgary
T2N 1N4
Canada

Phone +1 403-220-8563
Email mohtadi@ucalgary.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleElectrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial.
Study objectivesThis 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(s)Faculty of Medicine, University of Calgary - 15th July 1999.
Health condition(s) or problem(s) studiedShoulder instability
Intervention1. Open ICS (open capsular shift)
2. ETAC (Arthroscopic electrothermal capsulorrhaphy)
Intervention typeOther
Primary outcome measureShoulder stability measured by the Western Ontario Shoulder Instability Index (WOSI)
Secondary outcome measures1. Range of motion
2. Physical signs
3. Strength Instability
Overall study start date01/09/1999
Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants58
Key inclusion criteria1. Age 14 years or greater, either sex
2. Diagnosis of Multidirectional Instability (MDI)
3. Informed written consent
Key exclusion criteria1. Neurologic disorder (e.g. axillary nerve injury; Syringomyelia)
2. Cases involving third party compensation
3. Patients with primary posterior instability
Date of first enrolment01/09/1999
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Calgary
Calgary
T2N 1N4
Canada

Sponsor information

University of Calgary (Canada)
Not defined

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

ROR logo "ROR" https://ror.org/03yjb2x39

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2014 31/01/2019 Yes No

Editorial Notes

31/01/2019: Publication reference added