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Completed

NCT Number: NCT04258267

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Shoulder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Monica

Deurne, Antwerp, 2100, Belgium

About this study

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:

  • 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.
  • the inter- and intrarater reliability of the test battery used in this project, in the shoulder arthroplasty population.
  • the inter- and intrarater reliability of the shoulder joint position sense (SJPS) test and the shoulder joint force sensation (SFS) test.
  • the routines of the orthopedic shoulder surgeons before, during and after performing a shoulder arthroplasty.
  • the routines of physiotherapists in the post-operative rehabilitation of patients with shoulder arthroplasty.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Revision surgery

Treatment and study plan

Early mobilization

Procedure

Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative

Delayed mobilization

Procedure

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.

Primary outcomes

  1. Change in Shoulder Pain and Disability Index (SPADI)

    Time frame: 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 outcomes

  1. Shoulder pain

    Time frame: 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)

  2. Shoulder function

    Time frame: 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)

  3. Active ROM in shoulder abduction, anteflexion, internal rotation and external rotation

    Time frame: 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.

  4. Shoulder muscle strength in anteflexion, internal rotation, external rotation and the lift-off movement

    Time frame: 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.

  5. Proprioception (joint position sense)

    Time frame: 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.

  6. Proprioception (muscle force sensation)

    Time frame: 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.

  7. Patient related outcome measures (PROMS, EQ-D)

    Time frame: 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)

  8. Patient related outcome measures (PROMS, SST)

    Time frame: 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))

  9. Patient related outcome measures (PROMS, NRS)

    Time frame: 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))

  10. Patient related outcome measures (PROMS, DASH)

    Time frame: 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))

  11. Quality of Life (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty? A Prospective Longitudinal Study With Randomized Group Allocation, Towards Better Rehabilitation Strategies

Acronym: FINOSA

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2020
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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