An interventional study of Ultrasling® Quadrant and Bledsoe ARC® in Shoulder Injuries and Disorders, sponsored by Schulthess Klinik. Withdrawn at 2 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Schulthess Klinik · Not applicable, Interventional, and Treatment
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.
114 studies on the registry are indexed under Shoulder Injuries; 31 are open to participants now.
Browse Shoulder Injuries studies →Schulthess Klinik is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment.
Device: Ultrasling® Quadrant
Immobilization with the Bledsoe ARC® brace after surgical treatment.
Device: Bledsoe ARC®
Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment
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).
Time frame: 2 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
Plan to share: No
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This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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