Arthroplasty, Replacement, ShoulderFINOSANCT04258267
Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?
A study testing Early mobilization and Delayed mobilization in people with Arthroplasty, Replacement, Shoulder, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder
- What is being tested?
- Early mobilization and Delayed mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2020to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women >= 18 years of age
- Scheduled for primary shoulder arthroplasty
Who cannot join
- Revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Being tested
- Early mobilization, Delayed mobilization
- Keywords
- "Influencing factors", Rehabilitation, "Anatomical shoulder arthroplasty", "Reverse shoulder arthroplasty"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationProcedure or surgery
Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
Delayed mobilizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Experimental | Patients will be allowed to use their shoulder earlier. The immobilization period is shorter. Receives: Procedure: Early mobilization |
| Delayed mobilization | Experimental | The immobilization period is longer. Receives: Procedure: Delayed mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
It is measured with the Visual Analogue Scale (VAS)
Measured: 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
It is measured with the Constant and Murley Score (CS)
Measured: 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
It is measured with a Gravity-V inclinometer. The unit of measures is degrees.
Measured: 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
It is measured with a Handheld dynamometer. The unit of the measure is Newton.
Measured: 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)
Inclinometer and laser pointer are used to measure joint position sense in degrees.
Measured: Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Proprioception (muscle force sensation)
A handheld dynamometer is used to measure muscle force sensation in Newton.
Measured: Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, EQ-D)
Questionnaire Lynxcare (Euro Quality of Life, 5 dimensions (EQ-5D)
Measured: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, SST)
Questionnaire Lynxcare (Simple Shoulder Test (SST))
Measured: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, NRS)
Questionnaire Lynxcare (Numeric Rating Scale (NRS))
Measured: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, DASH)
Questionnaire Lynxcare (Disabilities of the Arm, Shoulder and Hand (DASH))
Measured: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Quality of Life (SF-36)
It is a questionnaire to measure patient health, comprising mental health as well as physical health.
Measured: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start14 Jan 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective longitudinal study with randomised group allocation, based on length of immobilization.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Filip Struyf, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258267
- Sponsor's protocol ID
- 19/48/559
- Acronym
- FINOSA
- Status last verified
- May 2026
- First submitted
- 16 Jan 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39556824
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04258267
- Acronym / sponsor ID
- FINOSA / 19/48/559
- Conditions
- Arthroplasty, Replacement, Shoulder
- Keywords
- "Influencing factors", Rehabilitation, "Anatomical shoulder arthroplasty", "Reverse shoulder arthroplasty"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective longitudinal study with randomised group allocation, based on length of immobilization.
| Arm | Type | Receives |
|---|---|---|
| Early mobilization | Experimental | Procedure: Early mobilizationPatients will be allowed to use their shoulder earlier. The immobilization period is shorter. |
| Delayed mobilization | Experimental | Procedure: Delayed mobilizationThe immobilization period is longer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult men and women >= 18 years of age
- Scheduled for primary shoulder arthroplasty
Key exclusion criteria (1 listed)
- Revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilizationPatients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative | Procedure or surgery | Early mobilization |
| Delayed mobilizationPatients will wear an abduction sling to immobilize the shoulder during the first 4 weeks post-operative, followed by an adduction sling for 2 weeks. | Procedure or surgery | Delayed mobilization |
Primary outcome
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.
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 39556824Claes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization and Delayed mobilization in people with Arthroplasty, Replacement, Shoulder, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04258267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.