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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05940974
• Other study ID #: 03.006.P.35.3
• Status: Active, not recruiting
• Start date: July 11, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Arthropathy

Intervention

Other:
• Questionnaire administration
All study participants will be surveyed with the EQ-5D-5L questionnaire to measure their quality of life indicators before the surgery and after the surgery (on 4 dates over a 1-year period); the DASH and ASES questionnaires to measure their functional outcomes before the surgery and after the surgery (on 4 dates over a 1-year period); the costs questionnaire to measure direct and indirect costs borne by patients because of their condition before the surgery and after the surgery (on 4 dates over a 1-year period).

Locations

Country	Name	City	State
Russian Federation	Traumatology, Orthopedics and Joint Pathology Clinic of the I.M. Sechenov First Moscow State Medical University (Sechenov University)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cost-utility of the primary total shoulder arthroplasty	As part of the cost-utility analysis (CUA), the Average Cost-Utility Ratio (ACUR) will be calculated for each time frame after the surgery. ACUR is equal to average health-related costs generated over a time frame divided by average Quality-Adjusted Life years (QALYs) gained over the same time frame. Health-related costs will include all direct and indirect costs before and after surgery (from questionnaires administered to patients and financial data taken from the cost accounting system of the facility). Data on health-related quality of life collected using the EuroQol-5 Dimension questionnaire (EQ-5D-5L) will inform the QALYs calculation.	Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Primary	Change in functional outcomes measured by total scores of the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire	The DASH questionnaire consists of 30 disability/symptom questions (items scored 1-5). To calculate the DASH disability/symptom score, values for all completed responses are summed and averaged. This produces a score out of five. This score is then transformed to a score out of 100 by subtracting one and multiplying by 25. There is also an optional work module which consists of 4 additional questions (items scored 1-5). The optional four-item module score is calculated in a similar way: all scores are summed up, divided by 4 to get the average, and the average minus 1 is multiplied by 25 to get a score out of 100.	Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Primary	Change in functional outcomes measured by total scores of the American Shoulder and Elbow Surgeons (ASES) questionnaire	The ASES questionnaire includes a section on pain (7 items, one of which is a visual analogue scale (VAS) of intensity of pain) and a section on activities of daily living (10 items scored 0-3). The ASES score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS score from 10 and multiplying it by 5. For the function score, values for all completed responses are summed and then multiplied by 5/3. The pain and function scores are then added together to obtain the final ASES score (out of 100).	Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Primary	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)	The EQ-5D-5L questionnaire consists of 5 questions in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In the 5-level version of the questionnaire, each domain has 5 levels. The 5 answers to the 5 questions are combined into a 5-digit number that describes the patients' health profile (state). The 5-digit number can be converted into a single summary index value, which reflects how good or bad a person's health is relative to the general population of a country or region. Another part of the questionnaire is the EQ-VAS which records the patients' self rated-health on a scale from 0 to 100, where 0 = the worst imaginable health and 100 = the best imaginable health.	Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary	Level of patients' satisfaction with the primary total hip arthroplasty procedure and overall treatment at the facility	This outcome measure consists of patients' answers to two questions: Patients will be asked to rate their level of satisfaction with the surgery, treatment provided at the clinic and their overall experience at the facility on a 0-10 numeric rating scale, where 0 = lowest level of satisfaction and 10 = highest level of satisfaction.; Patients will be asked whether they would choose to undergo this surgery at the same facility again if they had to (yes/no question).	Up to 7 days after the surgery