- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06281574
What Are the Determinants for RTW After SA (RTW after SA)
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
|
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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
Investigators
- Principal Investigator: Filip Verhaegen, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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