Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

Study Overview
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Brief Summary
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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.

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

Conditions
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Shoulder Injuries and Disorders

Intervention / Treatment
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* Device: Ultrasling® Quadrant
* Device: Bledsoe ARC®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each brace will be worn for either the first or second half (2 weeks) of the investigated immobilizing time of 4 week as determined by randomization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invervention 1<br>Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment. | Device: Ultrasling® Quadrant<br>* Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment<br>|
| Active Comparator: Intervention 2 (Control)<br>Immobilization with the Bledsoe ARC® brace after surgical treatment. | Device: Bledsoe ARC®<br>* Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall wearing comfort subjectively reported by patients | The primary outcome for this study is the overall level of comfort as perceived subjectively by the patients themselves by a questionnaire (NRS based). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in ADL | Patients will report subjectively their perceived pain in achieving activities of daily living on an NRS from 0 (no pain) to 10 (maximum pain) | 2 weeks | 
| Difficulty | Patients will report subjectively their perceived difficulty in achieving activities of daily living on an NRS from 0 (no difficulty) to 10 (maximum difficulty) | 2 weeks | 
| Comfort | Patients will report subjectively their perceived comfort in achieving activities of daily living on an NRS from 0 (no comfort) to 10 (maximum comfort) | 2 weeks | 
| Operability | The operability is reported by the level of difficulty of handling of the braces as evaluated subjectively by the patients by a questionnaire on an NRS from 0 (no difficulty) to 10 (maximum difficulty). The patients will also be asked about the total time they wear the brace during the day. | 2 weeks | 
| Stability | Stability of the shoulder braces is measured with digital photographs of the braces position at different time points throughout the immobilizing time. The photographs are evaluated digitally with inserted lines that allow angle measurement. The angles of the braces position are then compared to a) the position intended to be immobilized in by the surgeon and b) the position of the brace when being worn by the patient. Differences in the in the application by the patient in comparison to the application by a professional are documented by photographs and measured digitally as well. | 2 weeks | 
| Compliance | Patients will be required to wear their allocated brace 24 hours a day/7 days a week, but in clinical practice the PI noted them not sticking to this routine prescription for various reasons. The level of compliance in wearing the braces is an essential information gained by the trial. At weekly intervals patients will be asked to report the mean time their worn the allocated or any other brace during the preceding week (0-6 hours | >6-12 hours | >12-18 hours | >18-24 hours) which allows us to draw conclusions to their compliance. The reason(s) for removing the brace will be documented. | 2 weeks | 
| Patient's preference for any of the two braces | At the end of the 4-week immobilization period, patients will be asked about their preference for any of the two braces including an option for undecided patients. | 2 weeks |