Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

NCT ID: NCT05960838

Last Updated: 2023-07-27

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-01

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.

Detailed Description

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Conditions

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Shoulder Injuries and Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Invervention 1

Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment.

Group Type EXPERIMENTAL

Ultrasling® Quadrant

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Bledsoe ARC®

Intervention Type DEVICE

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

Intervention Type DEVICE

Bledsoe ARC®

Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Schulthess Klinik

Zurich, Canton of Zurich, Switzerland

Site Status

Schulthess Klinik

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ID OE-0108

Identifier Type: -

Identifier Source: org_study_id

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