Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty? A Prospective Longitudinal Study With Randomized Group Allocation, Towards Better Rehabilitation Strategies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthroplasty, Replacement, Shoulder
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Change in Shoulder Pain and Disability Index (SPADI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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: 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.
Investigators
Filip Struyf
Associate Professor
Universiteit Antwerpen
Eligibility Criteria
Inclusion Criteria
- •Adult men and women \>= 18 years of age
- •Scheduled for primary shoulder arthroplasty
Exclusion Criteria
- •Revision surgery
Outcomes
Primary Outcomes
Change in Shoulder Pain and Disability Index (SPADI)
Time Frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
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.
Secondary Outcomes
- Proprioception (muscle force sensation)(Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative)
- Shoulder pain(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(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)(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(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)(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(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, EQ-D)(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)(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)(Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative)
- Patient related outcome measures (PROMS, SST)(Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative)