Shoulder Arthropathy Clinical Trial
Official title:
Quality of Life, Functional Outcomes and Costs in Patients Undergoing Total Shoulder Arthroplasty
Verified date | June 2023 |
Source | I.M. Sechenov First Moscow State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
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 |
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