Shoulder Injuries and DisordersNCT05960838
Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace
A study testing Ultrasling® Quadrant and Bledsoe ARC® in people with Shoulder Injuries and Disorders, run by Schulthess Klinik at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injuries and Disorders
- What is being tested?
- Ultrasling® Quadrant and Bledsoe ARC®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Schulthess Klinik
Zurich, Canton of Zurich, 8008
Schulthess Klinik
Zurich, 8008
About this study
Official title: Evaluation of Functionality, Operability and Wearing Comfort of Two Multifunctional Shoulder Braces in Patients Who Underwent Shoulder Surgery
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
- Being tested
- Ultrasling® Quadrant, Bledsoe ARC®
- Medical subject headings
- Shoulder Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasling® QuadrantDevice
Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
Bledsoe ARC®Device
Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Invervention 1 | Experimental | Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment. Receives: Device: Ultrasling® Quadrant |
| Intervention 2 (Control) | Active comparator | Immobilization with the Bledsoe ARC® brace after surgical treatment. Receives: Device: Bledsoe ARC® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startJan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Why it stopped: The shoulder brace is being revised by the Producer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960838
- Sponsor's protocol ID
- ID OE-0108
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functionality, Operability and Wearing Comfort of Two Multifunctional Shoulder Braces in Patients Who Underwent Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05960838
- Acronym / sponsor ID
- ID OE-0108
- Conditions
- Shoulder Injuries and Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The shoulder brace is being revised by the Producer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Invervention 1 | Experimental | Device: Ultrasling® QuadrantImmobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment. |
| Intervention 2 (Control) | Active comparator | Device: Bledsoe ARC®Immobilization with the Bledsoe ARC® brace after surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasling® QuadrantImmobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment | Device | Invervention 1 |
| Bledsoe ARC®Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment | Device | Intervention 2 (Control) |
Primary outcome
Overall wearing comfort subjectively reported by patients
Time frame: 2 weeks
The primary outcome for this study is the overall level of comfort as perceived subjectively by the patients themselves by a questionnaire (NRS based).
7 secondary outcomes
Pain in ADL
Time frame: 2 weeks
Difficulty
Time frame: 2 weeks
Comfort
Time frame: 2 weeks
Operability
Time frame: 2 weeks
Stability
Time frame: 2 weeks
Compliance
Time frame: 2 weeks
Patient's preference for any of the two braces
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasling® Quadrant and Bledsoe ARC® in people with Shoulder Injuries and Disorders, run by Schulthess Klinik at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall wearing comfort subjectively reported by patients (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.