Health and Risk Factors in Patients With Hip and Knee Osteoarthritis
Keywords
Abstract
Description
Study design: This is a nationwide observational cohort study using prospectively obtained individual-level register data from five main sources; the BOA Register, the Swedish Hip Arthroplasty Register (SHAR), the Swedish Knee Arthroplasty Register (SKAR), Statistics Sweden and the National Board of Health and Welfare, Sweden. By using the personal identity number (PIN) that is unique to all citizens in Sweden, data will be merged together to create a research database that will be used for answering the following research questions in the study:
1. What are the differences between the population included in the BOA Register and the general Swedish population regarding health and socioeconomic factors?
2. What factors that predicts replacement surgery can be identified at the first registration in the BOA Register in patients with hip or knee osteoarthritis?
3. What factors that predicts outcome after replacement surgery can be identified at the first registration in the BOA Register in patients with hip or knee osteoarthritis?
Study population:The study cohort consists of all patients with a first registration (baseline) in the BOA Register between 2008 and 2016 (approximately n=75 000). These patients have sought treatment for knee and/or hip pain in primary health care in Sweden and been referred to the standardized core treatment of education and supervised exercises after confirmed clinical and/or radiographic osteoarthritis diagnose.
A control cohort (approximately n=225 000) covering the general Swedish population, who never have been included in the BOA register, will be recruited from the Swedish population register at Statistics Sweden and matched (1:3) to each patient in the study cohort by the same year of birth, gender and residence (as for the study cohort at baseline).
Data sources: In the study the investigators will collect the following data from the five registers: from the BOA Register: data reported by patients (e.g. most affected joint, pain, symptoms, health-related quality of life and physical activity level) and physiotherapists (e.g. earlier examinations and treatments) at baseline (the first registration before the standardized core treatment), and three and 12 months after. From the SHAR and the SKAR: patient-related and procedure-related data on all hip- and knee replacement surgeries in Sweden, including patient-reported outcomes (PROM) such as joint pain, health-related quality of life and satisfaction with treatment before surgery and one year postoperatively. From Statistics Sweden: data on socioeconomic factors and vital events such as birth, death, residence and marital status. From the National Board of Health and Welfare: data on comorbidity, health care consumption and expenditures of prescribed drugs.
Dates
Last Verified: | 04/30/2020 |
First Submitted: | 01/29/2018 |
Estimated Enrollment Submitted: | 02/11/2018 |
First Posted: | 02/19/2018 |
Last Update Submitted: | 05/25/2020 |
Last Update Posted: | 05/26/2020 |
Actual Study Start Date: | 12/31/2007 |
Estimated Primary Completion Date: | 11/30/2016 |
Estimated Study Completion Date: | 11/30/2021 |
Condition or disease
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Study cohort All patients with a first registration (baseline) in the BOA Register between 2008 and 2016 (approximately n=75 000). These patients have sought treatment for knee and/or hip pain in primary health care in Sweden and been referred to the standardized core treatment of education and supervised exercises after confirmed clinical and/or radiographic OA diagnose. | |
Control cohort Covering the general Swedish population, who never have been included in the BOA register, will be recruited from the Swedish population register at Statistics Sweden and matched (1:3) to each patient in the study cohort by the same year of birth, gender and residence (as for the study cohort at baseline) (approximately n=225 000). |
Eligibility Criteria
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | No |
Criteria | Inclusion Criteria: for participation in the standardized core treatment (of education and supervised exercises) and registration in the BOA Register are; - pain from the knee or hip. - diagnosis of osteoarthritis confirmed by a physical therapist, by medical history and a physical examination based on the clinical criteria for osteoarthritis Exclusion Criteria: for participation in the standardized core treatment and registration in the BOA Register are; - confirmed or suspicion of tumor, rheumatoid arthritis, sequel hip fracture, chronic pain or fibromyalgia, - total joint replacement within the past 12 months, - other surgery of the knee or hip joint within the past 3 months, - not able to read or understand Swedish |
Outcome
Primary Outcome Measures
1. Replacement surgery [up to the end of 2016]
Secondary Outcome Measures
1. Socioeconomic factors - marital status [at baseline]
2. Socioeconomic factors - education level [at baseline]
3. Socioeconomic factors - country of birth [at baseline]
4. Socioeconomic factors - occupation [at baseline]
5. Socioeconomic factors - income [within three years prior to baseline]
6. Socioeconomic factors - sick leave [within three years prior to baseline]
7. Consumption of drugs [within three years prior to baseline]
8. Death [up to the end of 2016]
9. Comorbidity [within three years prior to baseline]
10. Health care consumption [within three years prior to baseline]
11. Comorbidity [within three years prior to baseline]
12. Patient-reported outcome measure on most affected joint [at baseline, and at three and 12 months]
13. Patient-reported outcome measure on fear avoidance [at baseline, and at three and 12 months]
14. Patient-reported outcome measure on physical activity [at baseline, and at three and 12 months]
15. Patient-reported outcome measure on satisfaction with treatment [at baseline, and at three and 12 months]
16. Patient-reported outcome measure musculoskeletal comorbidity [at baseline, and at three and 12 months]
17. Patient-reported outcome measure on pain [at baseline, and at three and 12 months]
18. Patient-reported outcome measure on health-related quality of life [at baseline, and at three and 12 months]
19. Patient-reported outcome measure on self-efficacy [at baseline, and at three and 12 months]
20. Physiotherapist-reported earlier examinations [at baseline and at three months]
21. Physiotherapist-reported earlier interventions [at baseline and at three months]
22. Physiotherapist-reported compliance with intervention [at baseline and at three months]
23. Patient-reported outcome measures on satisfaction with treatment [before replacement surgery and at follow up one year]
24. Patient-reported outcome measures - musculoskeletal comorbidity [before replacement surgery and at follow up one year]
25. Patient-reported outcome measures - pain [before replacement surgery and at follow up one year]
26. Patient-reported outcome measures - health-related quality of life [before replacement surgery and at follow up one year]