Quality of Life, Functional Outcomes and Costs in Shoulder Arthroplasty

NCT05940974 | Unknown

• 1 other identifier: 03.006.P.35.3
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthropathy

Keywords

shoulder arthroplasty; shoulder replacement; quality of life; functional outcomes; costs; cost-utility analysis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Level of patients' satisfaction with the primary total hip arthroplasty procedure and overall treatment at the facility

  Up to 7 days after the surgery

Study Arms (1)

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.

Other: Questionnaire administration

Interventions

Questionnaire administration OTHER

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).

Shoulder arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, Russia

Location

Study Officials

• Ekaterina Aleksandrova

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 11, 2023
• Study Start: July 11, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)