Clinical trial NCT03438630: Health and Risk Factors in Patients With Hip and Knee Osteoarthritis
Official title: Health and Risk Factors in Patients With Hip and Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: socioeconomic factors
comorbidity
replacement surgery
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Linkoeping University
name: Jonkoping County Hospital
First posted: 2018-02-20
Enrollment: 288276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population who has received standardized core treatment of education and supervised exercises for hip and knee osteoarthritis and been registered in the BOA Register

Brief summary: Hip and knee osteoarthritis is one of the leading causes of global disability. There is no cure for the disease, but research and guidelines recommends that patients with osteoarthritis, early after the diagnosis, receive individually adapted physical exercises, information about their disease and about self-management and, if needed, recommendations on weight loss as a core treatment to prevent disability and impairment in health. This core treatment improves symptoms in osteoarthritis by reducing pain and increasing function, and have the potential to delay replacement surgery. In Sweden, core treatment has since 2008, been standardized in a supported self-management programme and evaluation and follow-ups are registered in the National Quality Register BOA (Better management of patients with OsteoArthritis). The course of deterioration in pain and physical functioning among different individuals with osteoarthritis is currently difficult to predict. Factors such as socioeconomic status and comorbidity contribute to progression of the disease, but are not fully established. There is a need for early identification of individuals who have a good prognosis with slow disease development and those that should be recommended joint replacement surgery in the future. Overriding aim of the study is to increase knowledge about the population who has received education and supervised exercises as a core treatment for hip and knee osteoarthritis and been registered in the BOA Register and to identify factors that can predict long-term outcome for this population.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Replacement surgery
timeFrame: up to the end of 2016
Secondary outcomes:
measure: Socioeconomic factors - marital status
timeFrame: at baseline
measure: Socioeconomic factors - education level
timeFrame: at baseline
measure: Socioeconomic factors - country of birth
timeFrame: at baseline
measure: Socioeconomic factors - occupation
timeFrame: at baseline
measure: Socioeconomic factors - income
timeFrame: within three years prior to baseline
measure: Socioeconomic factors - sick leave
timeFrame: within three years prior to baseline
measure: Consumption of drugs
timeFrame: within three years prior to baseline
measure: Death
timeFrame: up to the end of 2016
measure: Comorbidity
timeFrame: within three years prior to baseline
measure: Health care consumption
timeFrame: within three years prior to baseline
measure: Comorbidity
timeFrame: within three years prior to baseline
measure: Patient-reported outcome measure on most affected joint
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure on fear avoidance
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure on physical activity
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure on satisfaction with treatment
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure musculoskeletal comorbidity
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure on pain
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure on health-related quality of life
timeFrame: at baseline, and at three and 12 months
measure: Patient-reported outcome measure on self-efficacy
timeFrame: at baseline, and at three and 12 months
measure: Physiotherapist-reported earlier examinations
timeFrame: at baseline and at three months
measure: Physiotherapist-reported earlier interventions
timeFrame: at baseline and at three months
measure: Physiotherapist-reported compliance with intervention
timeFrame: at baseline and at three months
measure: Patient-reported outcome measures on satisfaction with treatment
timeFrame: before replacement surgery and at follow up one year
measure: Patient-reported outcome measures - musculoskeletal comorbidity
timeFrame: before replacement surgery and at follow up one year
measure: Patient-reported outcome measures - pain
timeFrame: before replacement surgery and at follow up one year
measure: Patient-reported outcome measures - health-related quality of life
timeFrame: before replacement surgery and at follow up one year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Vastra Gotaland
Study officials:
affiliation: Vastra Gotaland
name: Ola Rolfson, Ass profess
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustafsson K, Kvist J, Eriksson M, Dell'Isola A, Zhou C, Dahlberg LE, Rolfson O. Health status of individuals referred to first-line intervention for hip and knee osteoarthritis compared with the general population: an observational register-based study. BMJ Open. 2021 Sep 13;11(9):e049476. doi: 10.1136/bmjopen-2021-049476.
citation: Gustafsson K, Rolfson O, Eriksson M, Dahlberg L, Kvist J. Study protocol for an observational register-based study on health and risk factors in patients with hip and knee osteoarthritis. BMJ Open. 2018 Oct 3;8(10):e022812. doi: 10.1136/bmjopen-2018-022812.