Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960838
Status:
WITHDRAWN
Last Update Posted:
2023-07-27
First Post:
2020-10-20
Brief Title:
Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace
Sponsor:
Schulthess Klinik
Organization:
Schulthess Klinik
Study Overview
Official Title:
Evaluation of Functionality Operability and Wearing Comfort of Two Multifunctional Shoulder Braces in Patients Who Underwent Shoulder Surgery
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The shoulder brace is being revised by the Producer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Shoulder orthoses are an essential component of both postoperative care as well as a range of conservative treatment concepts and thus influence the functional outcome of a wide spectrum of glenohumeral pathologies Therefore it is important to look at them in greater detail
A new concept designed by DJO Global in the Ultrasling Quadrant orthosis now immobilizes only the glenohumeral joint while giving the possibility of elbow movement It also allows multiple settings concerning the position of the glenohumeral joint like internal rotation as well as neutral or external rotation It is yet to be seen how these changes will influence the outcome of therapy as well as how they will change the patients perception of the orthosis and its wearing comfort Therefore it is planned to be compared to another multifunctional shoulder brace already established on the domestic and international market the BledsoeARC brace
The primary objective is to assess if one of the investigated shoulder braces Ultrasling Quadrant or Bledsoe Arc is perceived by patients who received shoulder surgery as superior in terms of higher wearing comfort when worn during the post-operative immobilization period
A new concept designed by DJO Global in the Ultrasling Quadrant orthosis now immobilizes only the glenohumeral joint while giving the possibility of elbow movement It also allows multiple settings concerning the position of the glenohumeral joint like internal rotation as well as neutral or external rotation It is yet to be seen how these changes will influence the outcome of therapy as well as how they will change the patients perception of the orthosis and its wearing comfort Therefore it is planned to be compared to another multifunctional shoulder brace already established on the domestic and international market the BledsoeARC brace
The primary objective is to assess if one of the investigated shoulder braces Ultrasling Quadrant or Bledsoe Arc is perceived by patients who received shoulder surgery as superior in terms of higher wearing comfort when worn during the post-operative immobilization period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None