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

NCT04258267 | Completed

• 1 other identifier: 19/48/559
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Shoulder

Keywords

"Influencing factors"; Rehabilitation; "Anatomical shoulder arthroplasty"; "Reverse shoulder arthroplasty"

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Shoulder pain

  Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative

• Shoulder function

  Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative

• Active ROM in shoulder abduction, anteflexion, internal rotation and external rotation

  Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative

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

  Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative

• Proprioception (joint position sense)

  Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative

Study Arms (2)

Early mobilization

EXPERIMENTAL

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

Procedure: Early mobilization

Delayed mobilization

EXPERIMENTAL

The immobilization period is longer.

Procedure: Delayed mobilization

Interventions

Early mobilization PROCEDURE

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

Early mobilization

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.

Delayed mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Revision surgery

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

AZ Monica

Deurne, Antwerp, 2100, Belgium

Location

Related Publications (1)

• Claes A, De Mesel A, Struyf T, Verborgt O, Struyf F. Factors Influencing Outcome After Shoulder Arthroplasty (FINOSA Study): Protocol of a Prospective Longitudinal Study With Randomized Group Allocation. JMIR Res Protoc. 2024 Nov 18;13:e56522. doi: 10.2196/56522.

  PMID: 39556824 DERIVED

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The care provider and participant know the duration of the immobilization. The investigator and outcome assessor don't know the duration.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective longitudinal study with randomised group allocation, based on length of immobilization.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 6, 2020
• Study Start: January 14, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)