NCT05960838

Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

Evaluation of Functionality, Operability and Wearing Comfort of Two Multifunctional Shoulder Braces in Patients Who Underwent Shoulder Surgery

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 patient's 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.

Conditions

• Shoulder Injuries and Disorders

Interventions

Type	Name	Description
DEVICE	Ultrasling® Quadrant	Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
DEVICE	Bledsoe ARC®	Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

2 sites across 1 country: Switzerland