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Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

Primary Purpose

Shoulder Injuries and Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ultrasling® Quadrant
Bledsoe ARC®
Sponsored by
Schulthess Klinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries and Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Schulthess Klinik
  • Schulthess Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Invervention 1

Intervention 2 (Control)

Arm Description

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

Immobilization with the Bledsoe ARC® brace after surgical treatment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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)
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)
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.
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.
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.
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.

Full Information

First Posted
October 20, 2020
Last Updated
July 17, 2023
Sponsor
Schulthess Klinik
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1. Study Identification

Unique Protocol Identification Number
NCT05960838
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The shoulder brace is being revised by the Producer
Study Start Date
January 2026 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schulthess Klinik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries and Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Invervention 1
Arm Type
Experimental
Arm Description
Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment.
Arm Title
Intervention 2 (Control)
Arm Type
Active Comparator
Arm Description
Immobilization with the Bledsoe ARC® brace after surgical treatment.
Intervention Type
Device
Intervention Name(s)
Ultrasling® Quadrant
Intervention Description
Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
Intervention Type
Device
Intervention Name(s)
Bledsoe ARC®
Intervention Description
Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment
Primary Outcome Measure Information:
Title
Overall wearing comfort subjectively reported by patients
Description
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
Secondary Outcome Measure Information:
Title
Pain in ADL
Description
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
Title
Difficulty
Description
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
Title
Comfort
Description
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
Title
Operability
Description
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
Title
Stability
Description
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
Title
Compliance
Description
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
Title
Patient's preference for any of the two braces
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Schulthess Klinik
City
Zürich
State/Province
ZH
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
Schulthess Klinik
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

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