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 (NCT) | NCT00251160 |
| Protocol serial number | MCT-64671 |
| Sponsor | University of Calgary (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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
Scientific
University of Calgary
Sport Medicine Centre
2500 University Drive NW
Calgary
T2N 1N4
Canada
| Phone | +1 403-220-8563 |
|---|---|
| mohtadi@ucalgary.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial. |
| Study objectives | 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(s) | Faculty of Medicine, University of Calgary - 15th July 1999. |
| Health condition(s) or problem(s) studied | Shoulder instability |
| Intervention | 1. Open ICS (open capsular shift) 2. ETAC (Arthroscopic electrothermal capsulorrhaphy) |
| Intervention type | Other |
| Primary outcome measure(s) |
Shoulder stability measured by the Western Ontario Shoulder Instability Index (WOSI) |
| Key secondary outcome measure(s) |
1. Range of motion |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 58 |
| Key inclusion criteria | 1. Age 14 years or greater, either sex 2. Diagnosis of Multidirectional Instability (MDI) 3. Informed written consent |
| Key exclusion criteria | 1. Neurologic disorder (e.g. axillary nerve injury; Syringomyelia) 2. Cases involving third party compensation 3. Patients with primary posterior instability |
| Date of first enrolment | 01/09/1999 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Calgary
Calgary
T2N 1N4
Canada
T2N 1N4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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
