Health and Risk Factors in Patients With Hip and Knee Osteoarthritis

NCT03438630 | Completed

• 1 other identifier: 160176
• Study Type: observational
• Target: 288,276
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

socioeconomic factors; comorbidity; replacement surgery

Outcome Measures

Primary Outcomes (1)

• Replacement surgery

  Information from the SHAR and the SKAR Registers on eventual replacement surgery

  up to the end of 2016

Secondary Outcomes (26)

• Socioeconomic factors - marital status

  at baseline

• Socioeconomic factors - education level

  at baseline

• Socioeconomic factors - country of birth

  at baseline

• Socioeconomic factors - occupation

  at baseline

• Socioeconomic factors - income

  within three years prior to baseline

Study Arms (2)

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

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Linkoeping University: collaborator
• Jonkoping County Hospital: collaborator

Study Sites (1)

Vastra Gotaland

Gothenburg, Sweden

Location

Related Publications (3)

• 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.

  PMID: 37159269 DERIVED

• 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.

  PMID: 34518262 DERIVED

• 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.

  PMID: 30287673 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ola Rolfson, Ass profess

  Vastra Gotaland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 20, 2018
• Study Start: January 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2020
• Last Updated: September 23, 2025

Record last verified: 2021-10

Locations

SE (1)