Clinical trial NCT06281574: What Are the Determinants for RTW After SA
Official title: What Are the Determinants for Return to Work After Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Arthroplasty
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Return to work
timeFrame: Baseline
Secondary outcomes:
measure: Type of shoulder arthroplasty
timeFrame: Baseline
measure: WORQ-UP (work-related questionnaire for upper extremity disorders)
timeFrame: Baseline
measure: SSV (Subjective Shoulder Value)
timeFrame: Baseline
measure: SST (Dutch translation of the Simple Shoulder Test)
timeFrame: Baseline
measure: OSS (Oxford Shoulder Score)
timeFrame: Baseline
measure: Self-made questionnaire
timeFrame: Baseline
measure: Belgisch Kenniscentrum over welzijn op het werk (BeSWIC)
timeFrame: Baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Filip Verhaegen
role: PRINCIPAL_INVESTIGATOR
References: