What Are the Determinants for RTW After SA (RTW after SA)

July 24, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Population of patients with a shoulder arthroplasty surgery between January 2010 and January 2022 at University Hospitals Leuven.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 and > 63 years at time of surgery
  • Limited knowledge of Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of shoulder arthroplasty
Time Frame: Baseline
Collect how many participants received an anatomic total shoulder arthroplasty (aTSA), reverse total shoulder arthroplasty (rTSA) or humeral hemi-arthroplasty (HHA)
Baseline
SST (Dutch translation of the Simple Shoulder Test)
Time Frame: Baseline
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.
Baseline
OSS (Oxford Shoulder Score)
Time Frame: Baseline
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.
Baseline
Self-made questionnaire
Time Frame: Baseline
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.
Baseline
WORQ-UP (work-related questionnaire for upper extremity disorders)
Time Frame: Baseline
A questionnaire used to identify self-reported difficulty performing common work-related tasks. It consists of 17 items.
Baseline
SSV (Subjective Shoulder Value)
Time Frame: Baseline
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%.
Baseline
Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)
Time Frame: Baseline
The participants' occupations is classified as light, medium, hard or very hard occupation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Filip Verhaegen, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2024

Primary Completion (Actual)

March 27, 2025

Study Completion (Actual)

March 27, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • S67346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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