Shoulder ArthropathyNCT05940974
Quality of Life, Functional Outcomes and Costs in Shoulder Arthroplasty
An observational study of Shoulder Arthropathy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthropathy
- What is being tested?
- Questionnaire administration
- How many people
- 12 participants
- Where
- 1 siteRussia
- Study dates
- 11 Jul 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Traumatology, Orthopedics and Joint Pathology Clinic of the I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
Official title: Quality of Life, Functional Outcomes and Costs in Patients Undergoing Total Shoulder Arthroplasty
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.
Read the 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.
- Conditions
- Shoulder Arthropathy
- Being tested
- Questionnaire administration
- Keywords
- shoulder arthroplasty, shoulder replacement, quality of life, functional outcomes, costs, cost-utility analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Shoulder arthroplasty | All adult patients 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) who meet the inclusion criteria (described below) will be included. Receives: Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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.
Measured: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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).
Measured: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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.
Measured: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes (1)
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).
Measured: Up to 7 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start11 Jul 2023
- Primary completion20 Dec 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekaterina Aleksandrova, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940974
- Sponsor's protocol ID
- 03.006.P.35.3
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life, Functional Outcomes and Costs in Patients Undergoing Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT05940974
- Acronym / sponsor ID
- 03.006.P.35.3
- Conditions
- Shoulder Arthropathy
- Keywords
- shoulder arthroplasty, shoulder replacement, quality of life, functional outcomes, costs, cost-utility analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder arthroplasty | – | Other: Questionnaire administrationAll adult patients 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) who meet the inclusion criteria (described below) will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationAll 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). | Other | Shoulder arthroplasty |
Primary outcome
Change in cost-utility of the primary total shoulder arthroplasty
Time frame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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.
Change in functional outcomes measured by total scores of the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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.
Change in functional outcomes measured by total scores of the American Shoulder and Elbow Surgeons (ASES) questionnaire
Time frame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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).
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)
Time frame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
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.
1 secondary outcome
Level of patients' satisfaction with the primary total hip arthroplasty procedure and overall treatment at the facility
Time frame: Up to 7 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Aleksandrova study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthropathy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cost-utility of the primary total shoulder arthroplasty (time frame: Baseline (before surgery), 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.