Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT04258267
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2020-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?
Sponsor:
Universiteit Antwerpen
Organization:
Study Overview
Official Title:
Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty? A Prospective Longitudinal Study With Randomized Group Allocation, Towards Better Rehabilitation Strategies
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINOSA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: