Clinical trial NCT05960838: Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace
Official title: Evaluation of Functionality, Operability and Wearing Comfort of Two Multifunctional Shoulder Braces in Patients Who Underwent Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Injuries and Disorders
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall wearing comfort subjectively reported by patients
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain in ADL
timeFrame: 2 weeks
measure: Difficulty
timeFrame: 2 weeks
measure: Comfort
timeFrame: 2 weeks
measure: Operability
timeFrame: 2 weeks
measure: Stability
timeFrame: 2 weeks
measure: Compliance
timeFrame: 2 weeks
measure: Patient's preference for any of the two braces
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
state: ZH
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References: