Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?
- Conditions
- Arthroplasty, Replacement, Shoulder
- Interventions
- Procedure: Early mobilizationProcedure: Delayed mobilization
- Registration Number
- NCT04258267
- Lead Sponsor
- Universiteit Antwerpen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 97
- Adult men and women >= 18 years of age
- Scheduled for primary shoulder arthroplasty
- Revision surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early mobilization Early mobilization Patients will be allowed to use their shoulder earlier. The immobilization period is shorter. Delayed mobilization Delayed mobilization The immobilization period is longer.
- Primary Outcome Measures
Name Time Method Change in Shoulder Pain and Disability Index (SPADI) 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 Outcome Measures
Name Time Method Proprioception (muscle force sensation) Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative A handheld dynamometer is used to measure muscle force sensation in Newton.
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 It is measured with the Visual Analogue Scale (VAS)
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 It is measured with the Constant and Murley Score (CS)
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 Questionnaire Lynxcare (Numeric Rating Scale (NRS))
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 It is measured with a Gravity-V inclinometer. The unit of measures is degrees.
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 Questionnaire Lynxcare (Disabilities of the Arm, Shoulder and Hand (DASH))
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 It is measured with a Handheld dynamometer. The unit of the measure is Newton.
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 Questionnaire Lynxcare (Euro Quality of Life, 5 dimensions (EQ-5D)
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 It is a questionnaire to measure patient health, comprising mental health as well as physical health.
Proprioception (joint position sense) Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative Inclinometer and laser pointer are used to measure joint position sense in degrees.
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 Questionnaire Lynxcare (Simple Shoulder Test (SST))
Trial Locations
- Locations (1)
AZ Monica
🇧🇪Deurne, Antwerp, Belgium