The Right Treatment for the Right Patient At the Right Time. a Study Following 5,000 Patients with Knee Osteoarthritis

NCT ID: NCT03746184

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2025-07-31

Brief Summary

The treatment that patients with knee OA are offered varies largely. There is a need for more evidence-based individualized guidance to treatment choice for knee osteoarthritis. This study will register and evaluate the course and outcome of treatment in 5,000 patients with knee osteoarthritis. The understanding of knee OA treatment will advance in three ways: Firstly, by describing the different treatment pathways that are currently being used for knee OA. Secondly, by identifying wich individual factors that may impact the outcome of the treatment course. And finally, by conducting the economic burden related to different treatment modalities.

Detailed Description

The problem: Knee Osteoarthritis (OA), the most common form of arthritis, is a chronic, widespread disease with a steadily increasing prevalence that places a major economic burden on the society. Patients with knee OA suffer from chronic knee pain and functional disabilities. The treatment that patients with knee OA are offered varies largely, and is often not in coherence with clinical guidelines. The guidelines recommend patient education, exercise, and weight control as core interventions for all patients with knee OA and surgical intervention for end-stage knee OA. However, the timing of surgery is debated, and whether the outcome of different treatment strategies depend on individual factors such as the patients symptoms, OA severity, or prior treatment, has not been established.

The solution: This large-scale study aims at improving the understanding of which treatment should be offered to which patient with knee OA at which time. The study is an interdisciplinary, collaborative effort, including orthopaedic surgeons, physiotherapists and general practitioners from two different regions in Denmark. At least 5,000 patients with primary referrals to orthopaedic surgeons due to knee OA, at two public hospitals, will be recruited through a two-year inclusion period. Patients' prior treatment and symptom severity will be registered at the first consultation with the orthopaedic surgeon using a patient self-reported questionnaire. OA severity will be defined on plain standing knee radiographs using a well-established classification system. The course of treatment will be registered after 6 months and 2 years through a self-reported questionnaire with additional questions asking whether patients can accept their current symptom state, or, if not, whether they consider the treatment to have failed.

Societal impact and clinical implications: The understanding of knee OA treatment will advance in three ways: Firstly, our results will improve the overview by describing the different treatment pathways that are currently being used for knee OA. Secondly, predictors of good and poor treatment outcomes of different treatment modalities, or combinations hereof will be identified. And finally, the cost-effectiveness of different treatment modalities will be evaluated. These results will be used to develop a treatment algorithm to help patients with knee OA and clinicians to tailor the right treatment at the right time through shared decision-making.

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Knee osteoarthritis

Treatment course

Treatment course

Intervention Type: OTHER

Pursued treatment for knee OA, including type of health care provider, time period of treatment course, and types of treatments received, will be recorded via the patient-reported questionnaire.

Interventions

Treatment course

Pursued treatment for knee OA, including type of health care provider, time period of treatment course, and types of treatments received, will be recorded via the patient-reported questionnaire.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• primary referrals to one of two orthopedic department's outpatient clinics due to knee osteoarthritis

Exclusion Criteria

• previous total or unicompartmental knee replacement
• osteotomy around the study knee
• unable to read or write Danish
• patients who decline to answer the questionnaire at inclusion

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naestved Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

VIVE - The Danish Center for Social Science Research

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Troelsen

Professor, consultant, dr.med., PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Troelsen, Professor

Role: STUDY_CHAIR

Copenhagen University Hospital, Hvidovre, Denmark

Lina H Ingelsrud, PhD

Role: STUDY_CHAIR

Copenhagen University Hospital, Hvidovre, Denmark

Henrik M Schroeder, Asst. Prof.

Role: STUDY_CHAIR

Næstved Sygehus, Denmark

Søren T Skou, Assoc. Prof.

Role: STUDY_CHAIR

Næstved-Slagelse-Ringsted Hospitals AND University of Southern Denmark

Thomas Bandholm, Professor

Role: STUDY_CHAIR

University of Copenhagen AND Copenhagen University Hospital Hvidovre, Denmark

Jakob Kjellberg, Professor

Role: STUDY_CHAIR

VIVE - The Danish Centre of Applied Social Science, Denmark

Susanne Reventlow, Professor

Role: STUDY_CHAIR

University of Copenhagen

Anne Møller, Asst. Prof.

Role: STUDY_CHAIR

University of Copenhagen

Simon M Bruhn, M.Sc.

Role: STUDY_CHAIR

Copenhagen University Hospital, Hvidovre, Denmark

Locations

Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Countries

Denmark

References

Bruhn SM, Skou ST, Harris LK, Bandholm T, Moller A, Schroder HM, Troelsen A, Ingelsrud LH. Usage of guideline-adherent core treatments for knee osteoarthritis before and after consulting an orthopaedic surgeon: A prospective cohort study. Osteoarthr Cartil Open. 2023 Sep 28;5(4):100411. doi: 10.1016/j.ocarto.2023.100411. eCollection 2023 Dec.

Reference Type: DERIVED

PMID: 37818279 (View on PubMed)

Bruhn SM, Ingelsrud LH, Bandholm T, Skou ST, Schroder HM, Reventlow S, Moller A, Kjellberg J, Kallemose T, Troelsen A. Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study. BMJ Open. 2021 Jul 7;11(7):e048411. doi: 10.1136/bmjopen-2020-048411.

Reference Type: DERIVED

PMID: 34233992 (View on PubMed)

Other Identifiers

CAGROAD_TREATright_2018

Identifier Type: -

Identifier Source: org_study_id