Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251264
Status:
COMPLETED
Last Update Posted:
2015-07-13
First Post:
2005-11-08
Brief Title:
Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Arthroscopic Versus Open Stabilization of Traumatic Unidirectional Anterior Shoulder Instability A 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:
The purpose of this study is to compare arthroscopic and open shoulder stabilization procedures by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior instability of the shoulder at 2 and 5 years
Hypothesis There is no difference in disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability undergoing an arthroscopic versus an open stabilization procedure
Hypothesis There is no difference in disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability undergoing an arthroscopic versus an open stabilization procedure
Detailed Description:
Shoulder instability most commonly affects people in the late teens to mid thirties which are the most active years recreational and vocational The resulting disability time lost from work as well as the effect on an individuals quality of life represent a significant clinical problem for the population and for the healthcare system
The normal anatomy in the unstable shoulder can be restored using arthroscopic or open surgical stabilization techniques There is considerable controversy surrounding the issue of arthroscopic versus open shoulder stabilization Advocates of arthroscopic procedures cite the following as advantages faster recovery less post operative pain decreased operative time improved cosmetics greater return of shoulder motion and the more accurate identification of intraarticular pathology Those in favor of an open procedure cite superior long term results showing fewer recurrences with an open stabilization
There are few published reports directly comparing arthroscopic versus open shoulder stabilization repairs It is also difficult to compare the results of existing studies as they report on heterogeneous patient populations using a variety of techniques on mixed pathologies using different outcome scales and variable definitions of success and failure This study will address this controversial issue by comparing the disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability undergoing an arthroscopic versus an open stabilization procedure
This study is designed as a prospective randomized clinical trial with a second prospective analytical cohort study arm In the randomized arm patients are assigned to arthroscopic or open surgery based on varied block computer-generated randomization The expertise-based randomization method is used in this study whereby the surgeons perform either arthroscopic or open surgery but not both Therefore a patient is not only randomized to a treatment group but is also assigned to the expert surgeon for that treatment
Patients in the prospective analytical cohort study arm of the trial undergo shoulder stabilization open or arthroscopic with any surgeon and complete the same follow-up visits however they have not been randomized The outcomes of the prospective cohort will be compared to those of the randomized arm to determine if the expertise-based randomization method has an effect on patient outcome
Disease-specific quality of life is assessed using the validated Western Ontario Shoulder Instability WOSI Index The index has 21 questions divided into 4 categories physical symptoms sportrecreationwork lifestyle and emotions This self-administered questionnaire utilizes a 100mm visual analog scale format to provide an overall score out of 100 A lower score reflects a better quality of life
The normal anatomy in the unstable shoulder can be restored using arthroscopic or open surgical stabilization techniques There is considerable controversy surrounding the issue of arthroscopic versus open shoulder stabilization Advocates of arthroscopic procedures cite the following as advantages faster recovery less post operative pain decreased operative time improved cosmetics greater return of shoulder motion and the more accurate identification of intraarticular pathology Those in favor of an open procedure cite superior long term results showing fewer recurrences with an open stabilization
There are few published reports directly comparing arthroscopic versus open shoulder stabilization repairs It is also difficult to compare the results of existing studies as they report on heterogeneous patient populations using a variety of techniques on mixed pathologies using different outcome scales and variable definitions of success and failure This study will address this controversial issue by comparing the disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability undergoing an arthroscopic versus an open stabilization procedure
This study is designed as a prospective randomized clinical trial with a second prospective analytical cohort study arm In the randomized arm patients are assigned to arthroscopic or open surgery based on varied block computer-generated randomization The expertise-based randomization method is used in this study whereby the surgeons perform either arthroscopic or open surgery but not both Therefore a patient is not only randomized to a treatment group but is also assigned to the expert surgeon for that treatment
Patients in the prospective analytical cohort study arm of the trial undergo shoulder stabilization open or arthroscopic with any surgeon and complete the same follow-up visits however they have not been randomized The outcomes of the prospective cohort will be compared to those of the randomized arm to determine if the expertise-based randomization method has an effect on patient outcome
Disease-specific quality of life is assessed using the validated Western Ontario Shoulder Instability WOSI Index The index has 21 questions divided into 4 categories physical symptoms sportrecreationwork lifestyle and emotions This self-administered questionnaire utilizes a 100mm visual analog scale format to provide an overall score out of 100 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