The Right Treatment for the Right Patient at the Right Time. A Study Following 5,000 Patients With Knee Osteoarthritis (TREATright)

• ClinicalTrials.gov Identifier: NCT03746184
• Recruitment Status: Active, not recruiting
• First Posted: November 19, 2018
• Last Update Posted: January 8, 2021
• Sponsor: Hvidovre University Hospital
• Collaborators: Naestved Hospital; University of Copenhagen; VIVE - The Danish Center for Social Science Research; University of Southern Denmark
• Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Knee Osteoarthritis	Other: Treatment course

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: The Right Treatment for the Right Patient at the Right Time - A Prospective Cohort Study of 5,000 Patients With Knee Osteoarthritis
• Actual Study Start Date: October 23, 2018
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: July 31, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Knee osteoarthritis; Treatment course	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Patient Acceptable Symptom State (PASS) [ Time Frame: 2 years after inclusion ]
   Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
2. Treatment Failure [ Time Frame: 2 years after inclusion ]
   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.

Secondary Outcome Measures :

1. Patient Acceptable Symptom State (PASS) [ Time Frame: 6 months after inclusion ]
   Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
2. Treatment Failure [ Time Frame: 6 months after inclusion ]
   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.
3. Minimal Important Change [ Time Frame: 6 months and 2 years after inclusion ]
   An anchor question asking about the degree and importance of change in knee-pain and function will be answered on a 7-level Likert scale ranging from better, an important improvement to worse, an important deterioration.
4. Oxford Knee Score (OKS), range from 0 (worst) to 48 (best) [ Time Frame: 6 months and 2 years after inclusion ]
   Patient self-reported average knee pain and function during the past four weeks calculated from a validated 12-item questionnaire.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Locations

Denmark

Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650

Department of Orthopaedic Surgery, Næstved Sygehus

Næstved, Denmark, 4700

Sponsors and Collaborators

Hvidovre University Hospital

Naestved Hospital

University of Copenhagen

VIVE - The Danish Center for Social Science Research

University of Southern Denmark

Investigators

• Study Chair: Anders Troelsen, Professor; Copenhagen University Hospital, Hvidovre, Denmark
• Study Chair: Lina H Ingelsrud, PhD; Copenhagen University Hospital, Hvidovre, Denmark
• 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, Denmark

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bruhn SM, Ingelsrud LH, Bandholm T, Skou ST, Schroder HM, Reventlow S, Møller 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.

• Responsible Party: Anders Troelsen, Professor, consultant, dr.med., PhD, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT03746184
• Other Study ID Numbers: CAGROAD_TREATright_2018
• First Posted: November 19, 2018
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Decision in pending on whether the total database with all anonymised data will be transferred to the Danish National Archives' Collections once the study is completed.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anders Troelsen, Hvidovre University Hospital:

precision medicine; Patient-Specific Modeling

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases