What Are the Determinants for RTW After SA

Shoulder Arthroplasty Clinical Trial

— RTW after SA  

Official title:

What Are the Determinants for Return to Work After Shoulder Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06281574
• Other study ID #: S67346
• Status: Active, not recruiting
• Start date: February 13, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Arthroplasty

Intervention

Procedure:
• Questionnaires
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)

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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)	Baseline
Secondary	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.	Baseline
Secondary	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%.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)	The participants' occupations is classified as light, medium, hard or very hard occupation	Baseline