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NCT Number: NCT06281574

What Are the Determinants for RTW After SA

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.

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Key information

Conditions

Shoulder Arthroplasty

Age range

18 year–63 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Procedure

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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%.

  4. 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.

  5. 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.

  6. 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.

  7. Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)

    Time frame: Baseline

    The participants' occupations is classified as light, medium, hard or very hard occupation

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

What Are the Determinants for Return to Work After Shoulder Arthroplasty

Acronym: RTW after SA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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