Clinical trial NCT05940974: Quality of Life, Functional Outcomes and Costs in Shoulder Arthroplasty
Official title: Quality of Life, Functional Outcomes and Costs in Patients Undergoing Total Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Arthropathy
Keywords: shoulder arthroplasty
shoulder replacement
quality of life
functional outcomes
costs
cost-utility analysis
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative joint disease who are undergoing primary total shoulder arthroplasty at the Traumatology, Orthopedics and Joint Pathology Clinic of the I.M. Sechenov First Moscow State Medical University (Sechenov University)

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient is aged 18 years and over
* Patient is willing and able to provide written informed consent to participate in the study including the pre-surgery questionnaire and all post-surgical follow-up questionnaires
* Patient is diagnosed with degenerative joint disease and are admitted to the Traumatology, Orthopedics and Joint Pathology Clinic of the I.M. Sechenov First Moscow State Medical University (Sechenov University) to undergo primary total shoulder arthroplasty

Exclusion Criteria:

* Patient is unable to provide written consent due to illness or personal circumstances
* Patient is cognitively unable to complete study questionnaires
* Patient refuses to participate in any of the pre-surgery and post-surgical outcome measures (e.g., refuses to provide their contact information for follow-up surveys)
* Patient has an existing condition that would compromise their participation and follow-up in the study (e.g., neuromuscular and psychiatric disorders, musculoskeletal cancer)
* Patient is a pregnant woman

Primary outcomes:
measure: Change in cost-utility of the primary total shoulder arthroplasty
timeFrame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: Change in functional outcomes measured by total scores of the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: Change in functional outcomes measured by total scores of the American Shoulder and Elbow Surgeons (ASES) questionnaire
timeFrame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: Change in quality of life indicators measured by the 5-level version of the EuroQol-5 Dimension questionnaire (EQ-5D-5L) health profile (state), index and the visual analogue scale score (EQ VAS)
timeFrame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes:
measure: Level of patients' satisfaction with the primary total hip arthroplasty procedure and overall treatment at the facility
timeFrame: Up to 7 days after the surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Traumatology, Orthopedics and Joint Pathology Clinic of the I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Ekaterina Aleksandrova
role: STUDY_DIRECTOR
References: