Quality of Life, Functional Outcomes and Costs in Hip Arthroplasty

NCT ID: NCT05882656

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-31

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 hip arthroplasty (hip replacement) surgery.

Detailed Description

Primary total hip replacement surgery (also called primary total hip 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 hip 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 hip replacement surgeries are performed annually.

Functional outcomes and quality of life indicators will be measured with validated questionnaires. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used to measure functional outcomes in patients undergoing hip 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 hip replacement surgeries.

Conditions

Hip Arthropathy

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hip arthroplasty

All adult patients undergoing primary total hip 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.

Questionnaire administration

Intervention Type: OTHER

All study participants will be surveyed with the EQ-5D-5L questionnaire to measure their quality of life indicators before the primary total hip arthroplasty and after the surgery (on 4 dates over a 1-year period); the WOMAC questionnaire to measure their functional outcomes before the primary total hip arthroplasty 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 primary total hip arthroplasty and after the surgery (on 4 dates over a 1-year period).

Interventions

Questionnaire administration

All study participants will be surveyed with the EQ-5D-5L questionnaire to measure their quality of life indicators before the primary total hip arthroplasty and after the surgery (on 4 dates over a 1-year period); the WOMAC questionnaire to measure their functional outcomes before the primary total hip arthroplasty 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 primary total hip arthroplasty and after the surgery (on 4 dates over a 1-year period).

Intervention Type: OTHER

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
• Patients 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 hip 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekaterina Aleksandrova

Role: STUDY_DIRECTOR

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

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

03.006.P.35.1

Identifier Type: -

Identifier Source: org_study_id