- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960838
Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zürich, Switzerland, 8008
- Schulthess Klinik
-
-
ZH
-
Zürich, ZH, Switzerland, 8008
- Schulthess Klinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Invervention 1
Immobilization with the Ultrasling® Quadrant shoulder brace after surgical treatment.
|
Immobilization with the Ultrasling® Quadrant (DJO Global Switzerland Sàrl, Ecublens, Switzerland) shoulder brace after surgical treatment
|
Active Comparator: Intervention 2 (Control)
Immobilization with the Bledsoe ARC® brace after surgical treatment.
|
Immobilization with the Bledsoe ARC® (Breg Inc., Carlsbad, CA USA) brace after surgical treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain in ADL
Time Frame: 2 weeks
|
Patients will report subjectively their perceived pain in achieving activities of daily living on an NRS from 0 (no pain) to 10 (maximum pain)
|
2 weeks
|
Difficulty
Time Frame: 2 weeks
|
Patients will report subjectively their perceived difficulty in achieving activities of daily living on an NRS from 0 (no difficulty) to 10 (maximum difficulty)
|
2 weeks
|
Comfort
Time Frame: 2 weeks
|
Patients will report subjectively their perceived comfort in achieving activities of daily living on an NRS from 0 (no comfort) to 10 (maximum comfort)
|
2 weeks
|
Operability
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Stability
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Compliance
Time Frame: 2 weeks
|
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. |
2 weeks
|
Patient's preference for any of the two braces
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID OE-0108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Injuries and Disorders
-
Schulthess KlinikCompletedShoulder Injuries and DisordersSwitzerland
-
Istituto Nazionale Assicurazione contro gli Infortuni...Istituto Italiano di TecnologiaCompletedShoulder Injuries and DisordersItaly
-
CIT OrthoCompletedShoulder Injuries | Shoulder Disease | Knee Injuries and DisordersUnited States
-
Investigación en Hemofilia y FisioterapiaCompletedShoulder Injuries and DisordersSpain
-
Clinique Générale dAnnecyRecruitingDislocation ShoulderFrance
-
Spaarne GasthuisFlevoziekenhuis; Ziekenhuis Amstelland; OLVG; Gelre Hospitals; Medisch Spectrum TwenteNot yet recruitingShoulder Instability | Kinesiophobia | Shoulder Dislocation or Subluxation | Fear of Movement
-
University of FloridaMajor League BaseballCompletedShoulder Injuries | Shoulder Flexibility | Rotational Resistance of ShoulderUnited States
-
Encore Research Inc.CoolSystems, Inc.Completed
-
University of North Carolina, Chapel HillCompleted
-
University of ChileCompleted
Clinical Trials on Ultrasling® Quadrant
-
Lars AdolfssonRecruitingProximal Humeral FractureSweden
-
Shahid Beheshti University of Medical SciencesCompletedDiabetic Macular EdemaIran, Islamic Republic of
-
Mansoura UniversityWithdrawn
-
University of CataniaCompleted
-
Mayo ClinicCompletedArthroplasty, Replacement, Knee | Injuries, KneeUnited States
-
Mayo ClinicTerminatedBarrett's EsophagusUnited States
-
University of CataniaCompletedPeriodontal DiseasesItaly
-
Aydin Adnan Menderes UniversityCompleted
-
First Affiliated Hospital Xi'an Jiaotong UniversityUnknownSpinal NeoplasmsChina