Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251160
Status:
COMPLETED
Last Update Posted:
2015-07-13
First Post:
2005-11-07
Brief Title:
Electrothermal Arthroscopic Capsulorrhaphy ETAC and Open Inferior Capsular Shift in Patients With Shoulder Instability
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Arthroscopic Electrothermal Capsulorrhaphy ETAC Versus Open Inferior Capsular Shift ICS in Patients With Shoulder Instability A Multicentre Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy ETAC to the current reference standard procedure open inferior capsular shift ICS for the treatment of shoulder instability caused by ligamentous capsular redundancy Multi-directional instability MDI and multi-directional laxity with anteroinferior instability MDL-AII are the two types of shoulder instabilities included in this trial
Hypothesis There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy
Hypothesis There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy
Detailed Description:
The shoulder is the most frequently dislocated joint in the body Multiple causes and pathologies account for the various types of shoulder instability Multi-directional instability MDI and multi-directional laxity with anteroinferior instability MDL-AII are similar in pathology less common and more difficult to treat These types of shoulder instability are caused by ligamentous capsular redundancy When non-operative management fails for these patients their quality of life is significantly impaired and surgical treatment is required to tighten the loose ligaments and joint capsule A new way to treat these patients involves arthroscopic thermal shrinkage of the tissue to tighten the joint However there is a lack of scientific evidence to support the use of this technique called electrothermal arthroscopic capsulorrhaphy ETAC The current reference gold standard treatment for these patients is an open inferior capsular shift ICS procedure Therefore this trial will compare the effectiveness of these surgical techniques ETAC vs ICS in patients with MDI and MDL-AII by determining patient related quality of life
This study is designed as a multicentre randomized controlled trial Patients diagnosed with either MDI or MDL-AII who failed standardized non-operative management will undergo a diagnostic shoulder arthroscopy and if appropriate will be subsequently randomized in the operating room to either an ETAC or ICS surgical procedure Computer-generated stratified block randomization is used Stratification is based on two variables
1 surgeon - to account for any differences between surgeons and
2 diagnosis MDI or MDL-AII - to account for any differences in the severity of pathology
The disease-specific quality of life is assessed using a validated questionnaire the Western Ontario Shoulder Instability Index measured at baseline and 3 6 12 and 24 months The WOSI index has 21 questions divided into four categories to assess physical symptoms sportrecreationwork lifestyle and emotions Each question is scored out of 100 using a visual analog scale response format A lower score reflects a better quality of life
This study is designed as a multicentre randomized controlled trial Patients diagnosed with either MDI or MDL-AII who failed standardized non-operative management will undergo a diagnostic shoulder arthroscopy and if appropriate will be subsequently randomized in the operating room to either an ETAC or ICS surgical procedure Computer-generated stratified block randomization is used Stratification is based on two variables
1 surgeon - to account for any differences between surgeons and
2 diagnosis MDI or MDL-AII - to account for any differences in the severity of pathology
The disease-specific quality of life is assessed using a validated questionnaire the Western Ontario Shoulder Instability Index measured at baseline and 3 6 12 and 24 months The WOSI index has 21 questions divided into four categories to assess physical symptoms sportrecreationwork lifestyle and emotions Each question is scored out of 100 using a visual analog scale response format A lower score reflects a better quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN68224911 | REGISTRY | Current Controlled Trials | None |
| MCT-64671 CIHR | OTHER_GRANT | None | None |