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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty.
The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty. Therefore, factors such as patient characteristics, indication for procedure, pre-operative shoulder pain, pre-operative shoulder function, patient expectations, psychosocial factors, lifestyle factors, length of immobilization and soft tissue integrity, are subject to study.
Secondary aims are to investigate:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early mobilization | Experimental | Patients will be allowed to use their shoulder earlier. The immobilization period is shorter. |
|
| Delayed mobilization | Experimental | The immobilization period is longer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early mobilization | Procedure | Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shoulder Pain and Disability Index (SPADI) | There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome. | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain | It is measured with the Visual Analogue Scale (VAS) | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Shoulder function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica | Deurne | Antwerp | 2100 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39556824 | Derived | 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. |
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| ID | Term |
|---|---|
| D004434 | Early Ambulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Prospective longitudinal study with randomised group allocation, based on length of immobilization.
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The care provider and participant know the duration of the immobilization. The investigator and outcome assessor don't know the duration.
| Delayed mobilization | Procedure | 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. |
|
It is measured with the Constant and Murley Score (CS)
| Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Active ROM in shoulder abduction, anteflexion, internal rotation and external rotation | It is measured with a Gravity-V inclinometer. The unit of measures is degrees. | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Shoulder muscle strength in anteflexion, internal rotation, external rotation and the lift-off movement | It is measured with a Handheld dynamometer. The unit of the measure is Newton. | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Proprioception (joint position sense) | Inclinometer and laser pointer are used to measure joint position sense in degrees. | Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Proprioception (muscle force sensation) | A handheld dynamometer is used to measure muscle force sensation in Newton. | Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Patient related outcome measures (PROMS, EQ-D) | Questionnaire Lynxcare (Euro Quality of Life, 5 dimensions (EQ-5D) | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Patient related outcome measures (PROMS, SST) | Questionnaire Lynxcare (Simple Shoulder Test (SST)) | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Patient related outcome measures (PROMS, NRS) | Questionnaire Lynxcare (Numeric Rating Scale (NRS)) | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Patient related outcome measures (PROMS, DASH) | Questionnaire Lynxcare (Disabilities of the Arm, Shoulder and Hand (DASH)) | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| Quality of Life (SF-36) | It is a questionnaire to measure patient health, comprising mental health as well as physical health. | Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative |
| D013812 |
| Therapeutics |