Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

Schulthess Klinik

Status

Withdrawn

Conditions

Shoulder Injuries and Disorders

Treatments

Device: Ultrasling® Quadrant

Device: Bledsoe ARC®

Study type

Interventional

Funder types

Other

Identifiers

NCT05960838

ID OE-0108

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult patient (18 years or older)
Presence of one of the following defined shoulder pathologies with the corresponding surgical treatment:
Patients with isolated supraspinatus repairs in double row technique with or without biceps Treatment
Recurrent anterior instability without significant bone loss and arthroscopic Bankart repairs with three anchors
Rockwood Type V injury treated with arthroscopic-assisted low-profile TightRope Repair plus AC-Cerclage
Patients with rotator cuff arthropathy treated by reverse shoulder prosthesis
Signed Informed Consent to participate in the study

Exclusion criteria

Non-tolerance of one of the braces (e.g. allergy to textile component)
Presence of concurrent pathology of the contralateral arm , that interferes with the immobilizing treatment
Presence of another physical disability or health disorder (e.g. psychological disorders, dementia, ...) that make the handling of the braces more difficult or impossible
Patient perceived as being at risk of poor study compliance
Occurrence of an intra-operative adverse event likely to influence the post-operative immobilization and its evaluation
Inability to understand and speak German
Enrolment of the investigator, his/her family members, employees and other dependent persons