Quality of Life, Functional Outcomes and Costs in Shoulder Arthroplasty

Shoulder Arthropathy Clinical Trial

Official title: Quality of Life, Functional Outcomes and Costs in Patients Undergoing Total Shoulder Arthroplasty

Status Active, not recruiting

Clinical Trial Summary

This prospective observational study aims to collect and analyse data on functional outcomes, quality of life indicators, and costs in patients undergoing primary total shoulder arthroplasty (shoulder replacement) surgery.

Clinical Trial Description

Primary total shoulder replacement surgery (also called primary total shoulder arthroplasty) has been shown to be a safe and reliable procedure for the treatment of degenerative joint disease, which can improve the functional and overall quality of life among patients. This prospective observational study aims to explore how undergoing these surgeries affects patients' functional outcomes and quality of life indicators. Another purpose of this research is to evaluate the costs that generate from this surgical intervention and relate them to the gains in functional outcomes and quality of life measures by conducting cost-utility analysis (CUA).

Participants of this study will be men and non-pregnant women over the age of 18 who are undergoing primary total shoulder replacement surgery at the Traumatology, Orthopedics and Joint Pathology Clinic of the I.M. Sechenov First Moscow State Medical University (Sechenov University). At this facility, around 300 total shoulder replacement surgeries are performed annually.

Functional outcomes and quality of life indicators will be measured with validated questionnaires. The Disabilities of Arm, Shoulder and Hand (DASH) and the American Shoulder and Elbow Surgeons (ASES) questionnaires will be used to measure functional outcomes in patients undergoing shoulder arthroplasty, the 5-level version of the EuroQol-5 Dimension questionnaire (EQ-5D-5L) will be used to measure their health-related quality of life. Questionnaires will be administered to patients before they undergo the procedure and on several follow-up dates (6 weeks, 3 months, 6 months, 1 year after the procedure). Before the surgery the questionnaires will be provided to patients in print form. At other points in time the questionnaires will be administered over the phone or via online forms (way of questionnaire administration depends on the choices of patients).

In addition to tracking changes in patients' functional outcomes and quality of life indicators, patients will be surveyed about all direct and indirect costs generated from seeking treatment for their condition, undergoing the replacement surgery, and the rehabilitation process. A small sample of patients will be interviewed about the costs borne by them to produce a questionnaire which will be used to survey the other patients. Cost information will be collected at the same points in time and in the same formats as stated above (printed questionnaires, telephone surveys, online forms). Financial data for calculating costs borne by the clinic will be obtained from the cost accounting system of the facility after each patient's discharge. Afterwards, the collected cost information will be applied to the CUA. Using quality-adjusted life-years (QALYs) and monetary estimates of costs, Average Cost-Utility Ratios (ACURs) will be calculated for primary total shoulder replacement surgeries. ;

Related Conditions & MeSH terms

• Shoulder Arthropathy

• NCT number: NCT05940974
• Study type: Observational
• Source: I.M. Sechenov First Moscow State Medical University
• Status: Active, not recruiting
• Start date: July 11, 2023
• Completion date: December 2024