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

Arthroplasty, Replacement, Shoulder Clinical Trial

— FINOSA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04258267
• Other study ID #: 19/48/559
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: September 14, 2025

Study information

• Verified date: December 2022
• Source: Universiteit Antwerpen
• Contact: Anke Claes, PhD student
• Phone: 0032498040863
• Email: anke.claes[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: September 14, 2025
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Revision surgery

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Shoulder

Intervention

Procedure:
• Early mobilization
Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
• 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.

Locations

Country	Name	City	State
Belgium	AZ Monica	Deurne	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shoulder Pain and Disability Index (SPADI)	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.	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Shoulder pain	It is measured with the Visual Analogue Scale (VAS)	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Shoulder function	It is measured with the Constant and Murley Score (CS)	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Active ROM in shoulder abduction, anteflexion, internal rotation and external rotation	It is measured with a Gravity-V inclinometer. The unit of measures is degrees.	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Shoulder muscle strength in anteflexion, internal rotation, external rotation and the lift-off movement	It is measured with a Handheld dynamometer. The unit of the measure is Newton.	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Proprioception (joint position sense)	Inclinometer and laser pointer are used to measure joint position sense in degrees.	Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Proprioception (muscle force sensation)	A handheld dynamometer is used to measure muscle force sensation in Newton.	Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Patient related outcome measures (PROMS, EQ-D)	Questionnaire Lynxcare (Euro Quality of Life, 5 dimensions (EQ-5D)	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Patient related outcome measures (PROMS, SST)	Questionnaire Lynxcare (Simple Shoulder Test (SST))	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Patient related outcome measures (PROMS, NRS)	Questionnaire Lynxcare (Numeric Rating Scale (NRS))	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Patient related outcome measures (PROMS, DASH)	Questionnaire Lynxcare (Disabilities of the Arm, Shoulder and Hand (DASH))	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary	Quality of Life (SF-36)	It is a questionnaire to measure patient health, comprising mental health as well as physical health.	Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative