The Right Treatment for the Right Patient at the Right Time. A Study Following 5,000 Patients With Knee Osteoarthritis (TREATright)
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|ClinicalTrials.gov Identifier: NCT03746184|
Recruitment Status : Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : March 16, 2022
|Condition or disease||Intervention/treatment|
|Knee Osteoarthritis||Other: Treatment course|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746184
|Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre|
|Hvidovre, Denmark, 2650|
|Department of Orthopaedic Surgery, Næstved Sygehus|
|Næstved, Denmark, 4700|
|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|