Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?
NCT ID: NCT04258267
Last Updated: 2024-05-09
Study Results
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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RECRUITING
NA
97 participants
INTERVENTIONAL
2020-01-14
2025-09-14
Brief Summary
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Detailed Description
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Secondary aims are to investigate:
1. the influences of early mobilization vs. delayed mobilization of the shoulder after shoulder arthroplasty on post-operative shoulder pain, shoulder function and quality of life.
2. the inter- and intrarater reliability of the test battery used in this project, in the shoulder arthroplasty population.
3. the inter- and intrarater reliability of the shoulder joint position sense (SJPS) test and the shoulder joint force sensation (SFS) test.
4. the routines of the orthopedic shoulder surgeons before, during and after performing a shoulder arthroplasty.
5. the routines of physiotherapists in the post-operative rehabilitation of patients with shoulder arthroplasty.
6. the associations between the Patient Reported Outcome Measures (PROMS) used in AZ Monica and the Constant Murley Score (CS), and the PROMS and the Visual Analogue Scale (VAS).
and to conduct a questionnaire - and assess its reliability - measuring the expectations of the shoulder arthroplasty patients.
In order to reach the aims of this project, a prospective longitudinal study with randomized group allocation will be carried out over 48 months with estimated starting point in January 2020 and finishing in January 2024.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Early mobilization
Patients will be allowed to use their shoulder earlier. The immobilization period is shorter.
Early mobilization
Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
Delayed mobilization
The immobilization period is longer.
Delayed mobilization
Patients will wear an abduction sling to immobilize the shoulder during the first 4 weeks post-operative, followed by an adduction sling for 2 weeks.
Interventions
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Early mobilization
Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
Delayed mobilization
Patients will wear an abduction sling to immobilize the shoulder during the first 4 weeks post-operative, followed by an adduction sling for 2 weeks.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for primary shoulder arthroplasty
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
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Filip Struyf
Associate Professor
Locations
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AZ Monica
Deurne, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Claes A, De Mesel A, Struyf T, Verborgt O, Struyf F. Factors Influencing Outcome After Shoulder Arthroplasty (FINOSA Study): Protocol of a Prospective Longitudinal Study With Randomized Group Allocation. JMIR Res Protoc. 2024 Nov 18;13:e56522. doi: 10.2196/56522.
Other Identifiers
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19/48/559
Identifier Type: -
Identifier Source: org_study_id
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