NCT04258267

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroplasty, Replacement, Shoulder

Interventions

Type	Name	Description
PROCEDURE	Early mobilization	Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
PROCEDURE	Delayed mobilization	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.

Timeline

• Start date: 2020-01-14
• Primary completion: 2025-04-30
• Completion: 2025-09-14
• First posted: 2020-02-06
• Last updated: 2024-05-09

Locations

1 site across 1 country: Belgium