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

Universiteit Antwerpen

Status: Enrolling

Conditions: Arthroplasty, Replacement, Shoulder

Treatments: Procedure: Early mobilization; Procedure: Delayed mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04258267

19/48/559

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women >= 18 years of age
• Scheduled for primary shoulder arthroplasty

Exclusion criteria

• Revision surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 2 patient groups

Early mobilization

Experimental group

Description:

Patients will be allowed to use their shoulder earlier. The immobilization period is shorter.

Treatment:

Procedure: Early mobilization

Delayed mobilization

Experimental group

Description:

The immobilization period is longer.

Treatment:

Procedure: Delayed mobilization