OsteoarthritisNCT03438630
Health and Risk Factors in Patients With Hip and Knee Osteoarthritis
An observational study of Osteoarthritis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- How many people
- 288,276 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jun 2020
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- Child, Adult, Older adult
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
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- What are the differences between the population included in the BOA Register and the general Swedish population regarding health and socioeconomic factors?
- What factors that predicts replacement surgery can be identified at the first registration, 3 months and/or 12 months follow-up, in the BOA Register in patients with hip or knee osteoarthritis?
- What factors that predicts outcome after replacement surgery can be identified at the first registration, 3 months and/or 12 months follow-up 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.
- Conditions
- Osteoarthritis
- Keywords
- socioeconomic factors, comorbidity, replacement surgery
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Replacement surgery
Information from the SHAR and the SKAR Registers on eventual replacement surgery
Measured: up to the end of 2016
Secondary outcomes (26)
Socioeconomic factors - marital status
Data obtained from Statistics Sweden on marital status
Measured: at baseline
Socioeconomic factors - education level
Data obtained from Statistics Sweden on education level
Measured: at baseline
Socioeconomic factors - country of birth
Data obtained from Statistics Sweden on country of birth
Measured: at baseline
Socioeconomic factors - occupation
Data obtained from Statistics Sweden on occupation
Measured: at baseline
Socioeconomic factors - income
Data obtained from Statistics Sweden on income
Measured: within three years prior to baseline
Socioeconomic factors - sick leave
Data obtained from Statistics Sweden on sick leave
Measured: within three years prior to baseline
Consumption of drugs
Data on expenditures of prescribed drugs from the Swedish Prescribed Drug Register at the National Board of Health Care, Sweden
Measured: within three years prior to baseline
Death
eventually registered as dead by Statistics Sweden
Measured: up to the end of 2016
Comorbidity
Data from the National Board of Health and Welfare on registered ICD10-codes
Measured: within three years prior to baseline
Health care consumption
Data from the National Board of Health and Welfare on admission and discharge dates from health care units
Measured: within three years prior to baseline
Comorbidity
Data from the National Board of Health and Welfare on registered classification of surgical interventions
Measured: within three years prior to baseline
Patient-reported outcome measure on most affected joint
Data from the BOA Register on most affected joint
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure on fear avoidance
Data from the BOA Register on fear avoidance
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure on physical activity
Data from the BOA Register on physical activity level measured by questionnaire "In a typical week, how much time do you spend doing physical activity"
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure on satisfaction with treatment
Data from the BOA Register on satisfaction with treatment (the standardized core treatment) results measured by questionnaire
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure musculoskeletal comorbidity
Data from the BOA Register on musculoskeletal comorbidity measured in Charnley class (classifications of musculoskeletal impairment. Class A corresponds with unilateral hip or knee osteoarthritis (OA); Class B bilateral hip or knee OA; and Class C indicates multiple joint OA or some other condition that inhibits the patient's ability to walk)
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure on pain
Data from the BOA Register on pain in most affected joint, measured on VAS; (visual analogue scale) rating from 0-100, were 0 stands for no pain and 100 for maximum pain
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure on health-related quality of life
Data from the BOA Register on health-related quality of life measured by EuroQol 5-domain instrument (EQ-5D). The instrument consists of questions assessing 5 health outcome domains; mobility, self-care, usual activities, pain/discomfort and anxiety/ depression, and is summarized into a single score between 0 and 1 (full health). The instrument also includes a VAS assessing current overall health state scoring from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: at baseline, and at three and 12 months
Patient-reported outcome measure on self-efficacy
Data from the BOA Register on self-efficacy on ASES (Arthritis self-efficacy scale). ASES is a self-administered questionnaire which contains 11 items divided into 2 subgroups, self-efficacy pain and self-efficacy other symptoms. Each question is scored from 10 to 100, with "moderately certain" place midway between "very uncertain" and "very certain". Each subscale is scored separately, by taking the mean of the subscale items.
Measured: at baseline, and at three and 12 months
Physiotherapist-reported earlier examinations
Data from the BOA Register on earlier examinations of the affected joint prior to the standardized core treatment
Measured: at baseline and at three months
Physiotherapist-reported earlier interventions
Data from the BOA Register on earlier interventions, prior to the standardized core treatment
Measured: at baseline and at three months
Physiotherapist-reported compliance with intervention
Data from the BOA Register on compliance with the standardized core treatment intervention
Measured: at baseline and at three months
Patient-reported outcome measures on satisfaction with treatment
Data from the SHAR and the SKAR Register on satisfaction with treatment (replacement surgery)
Measured: before replacement surgery and at follow up one year
Patient-reported outcome measures - musculoskeletal comorbidity
Data from the SHAR and the SKAR Register on musculoskeletal comorbidity measured by Charnley class (Class A corresponds to unilateral hip/knee disease; Class B bilateral hip/knee disease; and Class C indicates multiple joint disease or some other condition that inhibits the patient's ability to walk).
Measured: before replacement surgery and at follow up one year
Patient-reported outcome measures - pain
Data from the SHAR and the SKAR Register on pain from a VAS; visual analogue scale rating from 0-100, were 0 stands for no pain and 100 for maximum pain
Measured: before replacement surgery and at follow up one year
Patient-reported outcome measures - health-related quality of life
Data from the SHAR and the SKAR Register on health-related quality of life measured by EuroQol 5-domain instrument (EQ-5D). The instrument consists of questions assessing 5 health outcome domains; mobility, self-care, usual activities, pain/discomfort and anxiety/ depression, and is summarized into a single score between 0 and 1 (full health). The instrument also includes a VAS assessing current overall health state scoring from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: before replacement surgery and at follow up one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startJan 2008
- Primary completionDec 2016
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 288,276 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Linkoeping University, Jonkoping County Hospital
- Responsible party
- Sponsor
- Investigators
- Ola Rolfson, Ass profess, Principal investigator, Vastra Gotaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438630
- Sponsor's protocol ID
- 160176
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2018
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gustafsson K, Kvist J, Eriksson M, Rolfson O. What Factors Identified in Initial Osteoarthritis Management Are Associated With Poor Patient-reported Outcomes After THA? A Register-based Study. Clin Orthop Relat Res. 2023 Sep 1;481(9):1732-1742. doi: 10.1097/CORR.0000000000002681. Epub 2023 May 9.
PubMed 37159269Gustafsson 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.
PubMed 34518262Gustafsson 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.
PubMed 30287673
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Risk Factors in Patients With Hip and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03438630
- Acronym / sponsor ID
- 160176
- Conditions
- Osteoarthritis
- Keywords
- socioeconomic factors, comorbidity, replacement surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288,276 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Linkoeping University, Jonkoping County Hospital
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 20 Feb 2018 (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.
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:
- What are the differences between the population included in the BOA Register and the general Swedish population regarding health and socioeconomic factors?
- What factors that predicts replacement surgery can be identified at the first registration, 3 months and/or 12 months follow-up, in the BOA Register in patients with hip or knee osteoarthritis?
- What factors that predicts outcome after replacement surgery can be identified at the first registration, 3 months and/or 12 months follow-up 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Replacement surgery
Time frame: up to the end of 2016
Information from the SHAR and the SKAR Registers on eventual replacement surgery
26 secondary outcomes
Socioeconomic factors - marital status
Time frame: at baseline
Socioeconomic factors - education level
Time frame: at baseline
Socioeconomic factors - country of birth
Time frame: at baseline
Socioeconomic factors - occupation
Time frame: at baseline
Socioeconomic factors - income
Time frame: within three years prior to baseline
Socioeconomic factors - sick leave
Time frame: within three years prior to baseline
Consumption of drugs
Time frame: within three years prior to baseline
Death
Time frame: up to the end of 2016
Comorbidity
Time frame: within three years prior to baseline
Health care consumption
Time frame: within three years prior to baseline
Comorbidity
Time frame: within three years prior to baseline
Patient-reported outcome measure on most affected joint
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure on fear avoidance
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure on physical activity
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure on satisfaction with treatment
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure musculoskeletal comorbidity
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure on pain
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure on health-related quality of life
Time frame: at baseline, and at three and 12 months
Patient-reported outcome measure on self-efficacy
Time frame: at baseline, and at three and 12 months
Physiotherapist-reported earlier examinations
Time frame: at baseline and at three months
Physiotherapist-reported earlier interventions
Time frame: at baseline and at three months
Physiotherapist-reported compliance with intervention
Time frame: at baseline and at three months
Patient-reported outcome measures on satisfaction with treatment
Time frame: before replacement surgery and at follow up one year
Patient-reported outcome measures - musculoskeletal comorbidity
Time frame: before replacement surgery and at follow up one year
Patient-reported outcome measures - pain
Time frame: before replacement surgery and at follow up one year
Patient-reported outcome measures - health-related quality of life
Time frame: before replacement surgery and at follow up one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Derived from this study: PubMed 37159269Gustafsson K, Kvist J, Eriksson M, Rolfson O. What Factors Identified in Initial Osteoarthritis Management Are Associated With Poor Patient-reported Outcomes After THA? A Register-based Study. Clin Orthop Relat Res. 2023 Sep 1;481(9):1732-1742. doi: 10.1097/CORR.0000000000002681. Epub 2023 May 9.
- Derived from this study: PubMed 34518262Gustafsson 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.
- Derived from this study: PubMed 30287673Gustafsson 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.
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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.
Ola Rolfson, Ass profess principal investigator
Vastra Gotaland
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 Osteoarthritis, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Replacement surgery (time frame: up to the end of 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438630, which also lists 3 linked publications.
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 23 Sep 2025.