Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

NCT05960838 | Withdrawn

• 1 other identifier: ID OE-0108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Injuries and Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain in ADL

  2 weeks

• Difficulty

  2 weeks

• Comfort

  2 weeks

• Operability

  2 weeks

• Stability

  2 weeks

Study Arms (2)

Invervention 1

EXPERIMENTAL

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

Device: Ultrasling® Quadrant

Intervention 2 (Control)

ACTIVE COMPARATOR

Immobilization with the Bledsoe ARC® brace after surgical treatment.

Device: Bledsoe ARC®

Interventions

Ultrasling® Quadrant DEVICE

Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment

Invervention 1

Bledsoe ARC® DEVICE

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

Intervention 2 (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (2)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

Schulthess Klinik

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Shoulder Injuries; Disease

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: July 27, 2023
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 27, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)