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

NCT03746184 | Active Not Recruiting

• 1 other identifier: CAGROAD_TREATright_2018
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

precision medicine; Patient-Specific Modeling

Outcome Measures

Primary Outcomes (2)

• Patient Acceptable Symptom State (PASS)

  Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.

  2 years after inclusion

• Treatment Failure

  Patients who answer "no" to the PASS question will also answer "yes/no" to a question about whether they consider the treatment received to have failed.

  2 years after inclusion

Secondary Outcomes (4)

• Patient Acceptable Symptom State (PASS)

  6 months after inclusion

• Treatment Failure

  6 months after inclusion

• Minimal Important Change

  6 months and 2 years after inclusion

• Oxford Knee Score (OKS), range from 0 (worst) to 48 (best)

  6 months and 2 years after inclusion

Study Arms (1)

Knee osteoarthritis

Treatment course

Other: Treatment course

Interventions

Treatment course 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.

Knee osteoarthritis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with primary referrals to one of two public hospitals orthopedic department's outpatient clinics due to knee osteoarthritis are consecutively invited to participate. The two hospitals cover the larger part of Zealand in Denmark.

You may qualify if:

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

You may not qualify if:

• previous total or unicompartmental knee replacement
• osteotomy around the study knee
• unable to read or write Danish

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Naestved Hospital: collaborator
• University of Copenhagen: collaborator
• VIVE - The Danish Center for Social Science Research: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• 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.

  PMID: 37818279 DERIVED

• 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.

  PMID: 34233992 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anders Troelsen, Professor

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

• Lina H Ingelsrud, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

• Henrik M Schroeder, Asst. Prof.

  Næstved Sygehus, Denmark

  STUDY CHAIR

• Søren T Skou, Assoc. Prof.

  Næstved-Slagelse-Ringsted Hospitals AND University of Southern Denmark

  STUDY CHAIR

• Thomas Bandholm, Professor

  University of Copenhagen AND Copenhagen University Hospital Hvidovre, Denmark

  STUDY CHAIR

• Jakob Kjellberg, Professor

  VIVE - The Danish Centre of Applied Social Science, Denmark

  STUDY CHAIR

• Susanne Reventlow, Professor

  University of Copenhagen

  STUDY CHAIR

• Anne Møller, Asst. Prof.

  University of Copenhagen

  STUDY CHAIR

• Simon M Bruhn, M.Sc.

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant, dr.med., PhD

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 19, 2018
• Study Start: October 23, 2018
• Primary Completion: April 27, 2023
• Study Completion: July 31, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

DK (1)