Health and Risk Factors in Patients With Hip and Knee Osteoarthritis

September 17, 2025 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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, 3 months and/or 12 months follow-up, 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, 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Vastra Gotaland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Replacement surgery
Time Frame: up to the end of 2016
Information from the SHAR and the SKAR Registers on eventual replacement surgery
up to the end of 2016

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Socioeconomic factors - marital status
Time Frame: at baseline
Data obtained from Statistics Sweden on marital status
at baseline
Socioeconomic factors - education level
Time Frame: at baseline
Data obtained from Statistics Sweden on education level
at baseline
Socioeconomic factors - country of birth
Time Frame: at baseline
Data obtained from Statistics Sweden on country of birth
at baseline
Socioeconomic factors - occupation
Time Frame: at baseline
Data obtained from Statistics Sweden on occupation
at baseline
Socioeconomic factors - income
Time Frame: within three years prior to baseline
Data obtained from Statistics Sweden on income
within three years prior to baseline
Socioeconomic factors - sick leave
Time Frame: within three years prior to baseline
Data obtained from Statistics Sweden on sick leave
within three years prior to baseline
Consumption of drugs
Time Frame: within three years prior to baseline
Data on expenditures of prescribed drugs from the Swedish Prescribed Drug Register at the National Board of Health Care, Sweden
within three years prior to baseline
Death
Time Frame: up to the end of 2016
eventually registered as dead by Statistics Sweden
up to the end of 2016
Comorbidity
Time Frame: within three years prior to baseline
Data from the National Board of Health and Welfare on registered ICD10-codes
within three years prior to baseline
Health care consumption
Time Frame: within three years prior to baseline
Data from the National Board of Health and Welfare on admission and discharge dates from health care units
within three years prior to baseline
Comorbidity
Time Frame: within three years prior to baseline
Data from the National Board of Health and Welfare on registered classification of surgical interventions
within three years prior to baseline
Patient-reported outcome measure on most affected joint
Time Frame: at baseline, and at three and 12 months
Data from the BOA Register on most affected joint
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
Data from the BOA Register on fear avoidance
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
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"
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
Data from the BOA Register on satisfaction with treatment (the standardized core treatment) results measured by questionnaire
at baseline, and at three and 12 months
Patient-reported outcome measure musculoskeletal comorbidity
Time Frame: at baseline, and at three and 12 months
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)
at baseline, and at three and 12 months
Patient-reported outcome measure on pain
Time Frame: at baseline, and at three and 12 months
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
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
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).
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
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.
at baseline, and at three and 12 months
Physiotherapist-reported earlier examinations
Time Frame: at baseline and at three months
Data from the BOA Register on earlier examinations of the affected joint prior to the standardized core treatment
at baseline and at three months
Physiotherapist-reported earlier interventions
Time Frame: at baseline and at three months
Data from the BOA Register on earlier interventions, prior to the standardized core treatment
at baseline and at three months
Physiotherapist-reported compliance with intervention
Time Frame: at baseline and at three months
Data from the BOA Register on compliance with the standardized core treatment intervention
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
Data from the SHAR and the SKAR Register on satisfaction with treatment (replacement surgery)
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
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).
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
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
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
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).
before replacement surgery and at follow up one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
Jonkoping County Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ola Rolfson, Ass profess, Vastra Gotaland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 160176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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