Shoulder ArthroplastyRTW after SANCT06281574
What Are the Determinants for RTW After SA
An observational study of Shoulder Arthroplasty, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- Shoulder Arthroplasty
- What is being tested?
- Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Feb 2024to 27 Mar 2025
- Phase
- Observational
- 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 to 63 years
- All sexes
- No healthy volunteers
- Adult
Study population: Population of patients with a shoulder arthroplasty surgery between January 2010 and January 2022 at University Hospitals Leuven.
Who may be able to join
- Current evidence suggests that no significant changes in functionality can be expected 2 years after surgery. Therefore, we will include patients who were operated between January 2010 and January 2022 at the University Hospital Leuven
- Patients ≥ 18 years old and ≤ 63 years old at time of surgery
- Implantation of an anatomic total shoulder arthroplasty, humeral head hemi arthroplasty or reversed shoulder arthroplasty
Who cannot join
- Age < 18 and > 63 years at time of surgery
- Limited knowledge of Dutch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are the Determinants for Return to Work After Shoulder Arthroplasty
Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.
Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.
This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW.
Read the detailed description
Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients, due to the high incidence of complications and the limited longevity of the implant. Therefore, this type of surgery remained reserved for the elderly patients. During the last decades however, improvement of surgical techniques and implants have made it possible to expand the indications for anatomical total shoulder arthroplasty (aTSA), humeral head hemi-arthroplasty (HHA) and reversed total shoulder arthroplasty (rTSA), resulting in significant improvements in range of motion, functional outcomes, quality of life and reported pain scores. As a result, these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.
Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.
This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW. An enhanced understanding of this social, medical and economic issue will enable surgeons to give more tailored advice to their patients regarding RTW after shoulder replacement surgery and accordingly reduce the economic burden on Belgian society.
- Conditions
- Shoulder Arthroplasty
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesProcedure or surgery
To assess the shoulder function, the following questionnaires will be used:
The validated Dutch translation of the Oxford Shoulder Score (OSS) The validated Dutch translation of the Simple Shoulder Test (SST) The Subjective Shoulder Value (SVV) To assess the work ability patients will use the validated Dutch work-related questionnaire for upper extremity disorders (WORQ-UP)
| Study group | Role | What they receive |
|---|---|---|
| Patients with shoulder arthroplasty | Including all surgical interventions (anatomic total shoulder arthroplasty, humeral head hemi arthroplasty or reversed shoulder arthroplasty) for patients with shoulder arthroplasty Receives: Procedure: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Collection how many of the study participants will return to work after a shoulder arthroplasty. This question is answered with yes or no.
Measured: Baseline
Secondary outcomes (7)
Type of shoulder arthroplasty
Collect how many participants received an anatomic total shoulder arthroplasty (aTSA), reverse total shoulder arthroplasty (rTSA) or humeral hemi-arthroplasty (HHA)
Measured: Baseline
WORQ-UP (work-related questionnaire for upper extremity disorders)
A questionnaire used to identify self-reported difficulty performing common work-related tasks. It consists of 17 items.
Measured: Baseline
SSV (Subjective Shoulder Value)
Question to subjectively evaluate a patient's shoulder function. Which percentage do you give your shoulder. A normal shoulder is 100% and worst schoulder is 0%.
Measured: Baseline
SST (Dutch translation of the Simple Shoulder Test)
A questionnaire that contains 12 items to be answered by the patient independently: 2 about function related to pain, 7 about function/strength, and 3 about range of motion. Questions are answered by yes or no. A final score of 0 = worst and 12 = best. Scores are subsequently transformed by number of 'yes' items/ number of completed items x 100 = % 'yes' responses. A final score of 0= worst function and 100= best function.
Measured: Baseline
OSS (Oxford Shoulder Score)
A questionnaire that contains 12 items to be answered by the patient independently. There are 5 categories of response for every question, corresponding to a score ranging from 1 to 5. Scores are combined to give a single score, with a range from 12 (best) to 60 (worst). The questions deal with pain (degree, time point) and possible handicaps in private and professional life. It is divided 20/40 corresponding to pain/activities of daily living.
Measured: Baseline
Self-made questionnaire
A questionnaire where the participants is asked if they returned back to their jobs and if so how many months after surgery, what their job satisfaction is, if work-related adaptations were made by the employer to ease the return to work process, what their marital status and educational qualifications are.
Measured: Baseline
Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)
The participants' occupations is classified as light, medium, hard or very hard occupation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start13 Feb 2024
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Verhaegen, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281574
- Sponsor's protocol ID
- S67346
- Acronym
- RTW after SA
- Status last verified
- Jul 2025
- First submitted
- 19 Feb 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Determinants for Return to Work After Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06281574
- Acronym / sponsor ID
- RTW after SA / S67346
- Conditions
- Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 28 Feb 2024 (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.
Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.
Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.
This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW.
Detailed description
Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients, due to the high incidence of complications and the limited longevity of the implant. Therefore, this type of surgery remained reserved for the elderly patients. During the last decades however, improvement of surgical techniques and implants have made it possible to expand the indications for anatomical total shoulder arthroplasty (aTSA), humeral head hemi-arthroplasty (HHA) and reversed total shoulder arthroplasty (rTSA), resulting in significant improvements in range of motion, functional outcomes, quality of life and reported pain scores. As a result, these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.
Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.
This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW. An enhanced understanding of this social, medical and economic issue will enable surgeons to give more tailored advice to their patients regarding RTW after shoulder replacement surgery and accordingly reduce the economic burden on Belgian society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with shoulder arthroplasty | – | Procedure: QuestionnairesIncluding all surgical interventions (anatomic total shoulder arthroplasty, humeral head hemi arthroplasty or reversed shoulder arthroplasty) for patients with shoulder arthroplasty |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Population of patients with a shoulder arthroplasty surgery between January 2010 and January 2022 at University Hospitals Leuven.
Key inclusion criteria (3 listed)
- Current evidence suggests that no significant changes in functionality can be expected 2 years after surgery. Therefore, we will include patients who were operated between January 2010 and January 2022 at the University Hospital Leuven
- Patients ≥ 18 years old and ≤ 63 years old at time of surgery
- Implantation of an anatomic total shoulder arthroplasty, humeral head hemi arthroplasty or reversed shoulder arthroplasty
Key exclusion criteria (2 listed)
- Age < 18 and > 63 years at time of surgery
- Limited knowledge of Dutch
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 |
|---|---|---|
| QuestionnairesTo assess the shoulder function, the following questionnaires will be used: The validated Dutch translation of the Oxford Shoulder Score (OSS) The validated Dutch translation of the Simple Shoulder Test (SST) The Subjective Shoulder Value (SVV) To assess the work ability patients will use the validated Dutch work-related questionnaire for upper extremity disorders (WORQ-UP) | Procedure or surgery | Patients with shoulder arthroplasty |
Primary outcome
Return to work
Time frame: Baseline
Collection how many of the study participants will return to work after a shoulder arthroplasty. This question is answered with yes or no.
7 secondary outcomes
Type of shoulder arthroplasty
Time frame: Baseline
WORQ-UP (work-related questionnaire for upper extremity disorders)
Time frame: Baseline
SSV (Subjective Shoulder Value)
Time frame: Baseline
SST (Dutch translation of the Simple Shoulder Test)
Time frame: Baseline
OSS (Oxford Shoulder Score)
Time frame: Baseline
Self-made questionnaire
Time frame: Baseline
Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)
Time frame: Baseline
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 29 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Shoulder Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Recruiting
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Reverse Shoulder Arthroplasty
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Recruiting
Driving After Shoulder Surgery
Shoulder
Active, not recruitingObservational study
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
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.
Filip Verhaegen principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroplasty, run by Universitaire Ziekenhuizen KU Leuven 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 3 inclusion and 2 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 29 Jul 2025. 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?
Return to work (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.