Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2026-01-31
2028-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Invervention 1
Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment.
Ultrasling® Quadrant
Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
Intervention 2 (Control)
Immobilization with the Bledsoe ARC® brace after surgical treatment.
Bledsoe ARC®
Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment
Interventions
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Ultrasling® Quadrant
Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
Bledsoe ARC®
Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Schulthess Klinik
OTHER
Responsible Party
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Locations
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Schulthess Klinik
Zurich, Canton of Zurich, Switzerland
Schulthess Klinik
Zurich, , Switzerland
Countries
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Other Identifiers
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ID OE-0108
Identifier Type: -
Identifier Source: org_study_id
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