Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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: 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. the inter- and intrarater reliability of the test battery used in this project, in the shoulder arthroplasty population. the inter- and intrarater reliability of the shoulder joint position sense (SJPS) test and the shoulder joint force sensation (SFS) test. the routines of the orthopedic shoulder surgeons before, during and after performing a shoulder arthroplasty. the routines of physiotherapists in the post-operative rehabilitation of patients with shoulder arthroplasty. 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.

Official Title
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Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty? A Prospective Longitudinal Study With Randomized Group Allocation, Towards Better Rehabilitation Strategies

Conditions
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Arthroplasty, Replacement, Shoulder

Intervention / Treatment
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* Procedure: Early mobilization
* Procedure: Delayed mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women >= 18 years of age Scheduled for primary shoulder arthroplasty Exclusion Criteria: Revision surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective longitudinal study with randomised group allocation, based on length of immobilization.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilization<br>Patients will be allowed to use their shoulder earlier. The immobilization period is shorter. | Procedure: Early mobilization<br>* Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative<br>|
| Experimental: Delayed mobilization<br>The immobilization period is longer. | Procedure: Delayed mobilization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influencing factors, Rehabilitation, Anatomical shoulder arthroplasty, Reverse shoulder arthroplasty